Patients fitted with Stryker's Spine OASYS Midline Occiput Plate implant during a spinal revision surgery between April 2010 and February 2013.
It has been alleged the device's pin can fracture after implant which can expose patients to serious adverse health risks including blood loss, nerve damage and corrective surgery.
The OASYS Midline Occiput Plate is used to promote fusion of the cervical spine and to provide stabilization between the occipital bone and vertebrae in the spine during the patient's recovery.
On May 30, 2013, Stryker and the FDA announced a Class I recall for the medical device maker's OASYS Midline Occiput Plate.
Patients who have experienced severe adverse health complications including blood loss, nerve damage and revision surgeries after being implanted with an OASYS Midline Occiput Plate implant during spinal revision surgery may have legal recourse. It has been reported that after the device is implanted, the pin holding the tulip head to the product’s stabilization structure may fracture, causing the precisely-placed device to shift. This could potentially cause life-threatening side effects.
Did you suffer post-operative side effects after receiving anOASYSMidline Occiput Plate implant?
OASYS Midline Occiput Plate for Spinal Stabilization
The OASYS Midline Occiput Plate device was, according to Stryker, “developed to provide the surgeon with unsurpassed versatility for the treatment of pathologies of the occipitocervical junction and the posterior cervical and upper thoratic spine (occiput-T3).” Intended to help individuals who had sustained severe spinal injuries, the OASYS is a temporary device designed to promote fusion of the cervical spine and provide stabilization between the occipital bone and vertebrae in the spine during the patient’s recovery. The delicate area of the body in which this surgery occurs requires precise placement of the device, and should the device shift, it could pose risk of damage to the spinal cord.
Stryker OASYS Device Failure
Patients have reported the following complications in association with the OASYS Midline Occiput Plate:
The need for revision surgery to replace the device
Allegedly, the pin holding the tulip head to the plate body, which provides stabilization in a very sensitive area of the spine, may fracture. Once the pin fractures, the tulip head may detach from the base of the device, potentially causing it to shift from its intended position. This would alter the way in which the product was carefully placed in the spinal area and allegedly could cause severe injuries.
FDA Announces Recall of a Potentially Lethal Product
On May 30, 2013, after receiving notice of serious complications associated with the implant, Stryker issued an Urgent Medical Device Recall advising all hospitals to immediately stop using the device, review their inventory, and return any remaining devices to the company. The FDA announced the Class I Recall, which is the “most serious type of recall and involves situations in which there is a reasonable probability that use of [the] [product] will cause serious adverse health consequences or death.”
All patients who received the an implant distributed between April 23, 2010 and February 12, 2013 are urged to return to their physician for a post-operative plate evaluation to determine if the implant was faulty or if serious side effects may manifest. Even if side effects or symptoms have not manifested they may do so in the future.
If you had spinal surgery using an OASYS Midline Occiput Plate implant to stabilize the damaged site, you may have legal recourse.