MAUDE Adverse Event Report: STRYKER SPINE-US 6.5X50 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482616550
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was presented with a leg pain post-operatively.A post-op x-ray showed a compromised structure and potential dislodgement of cage.Further communication with sales rep and ct scan review confirmed that the cage had not been dislodged.An x-ray showed the screw has protruded through the vertebral body into disc space.A revision surgery was performed to remove screw and construct extension from l3-s1.
Event or Problem Description
It was reported that the patient was presented with a leg pain post-operatively.A post-op x-ray showed a compromised structure and potential dislodgement of cage.Further communication with sales rep and ct scan review confirmed that the cage had not been dislodged.An x-ray showed the screw has protruded through the vertebral body into disc space.A revision surgery was performed to remove screw and construct extension from l3-s1.
Additional Manufacturer Narrative
Visual, dimensional, functional inspection, and material analysis could not be performed as the device was discarded by the hospital.Complaint history records were reviewed for the lot number provided and no similar events were identified.Manufacturing history records were reviewed for the lot number provided and no relevant manufacturing issues were identified.It was reported that the bony anatomy was fractured/deformed and a ¿compromised structure,¿ which included vertebral bodies and pedicles, were confirmed via x-ray.Additionally, the screws protruded through the vertebral body at l4 into the disc space above.A definitive root cause could not be determined, but the patient's poor bone quality, due to osteoporosis, most likely contributed to the screw migration.Osteoporosis is listed as a contraindication in the ifu."poor bone quality can affect the structure integrity and possibly cause the screws to pullout or migrate as the screw purchase may not be as strong as in healthy bone." from the ifu: ¿the surgeon must warn the patient of the surgical risks and make aware of possible adverse effects.The surgeon must warn the patient that the devices cannot and do not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implants can break or become damaged as a result of strenuous activity or trauma, and that the devices may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the devices.Patients who smoke have been shown to have an increased incidence of non-unions.Surgeons must advise patients of this fact and warn of the potential consequences.For diseased patients with degenerative disease, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance.In such cases, orthopaedic devices may be considered only as a delaying technique or to provide temporary relief.¿.

• Brand Name: 6.5X50 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8467389
• Report Number: 3005525032-2019-00028
• Device Sequence Number: 13956910
• Product Code: NKB
• UDI-Device Identifier: 07613327351552
• UDI-Public: 07613327351552
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 482616550
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR