MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY THREE LEVEL PLATE SIZE 48; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48811348
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); No Code Available (3191)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery to replace a plate and screws, as the screws were backing out.
Event or Problem Description
It was reported that the patient underwent revision surgery to replace a plate and screws, as the screws were backing out.
Additional Manufacturer Narrative
Catalog #: 48811348, lot #: 164097.Gtin #: ( b)(4).Method: visual inspection, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed by the provided x-ray.A revision surgery occurred and the implants were returned for examination.The visual inspection found the plate to have a broken spring bar and screw shave no anomalies associated.Manufacturing files were reviewed and no anomalies were found.Conclusion: the exact root cause could not determined.The potential root causes include, poor surgical candidate or bone quality, excessive post-op activity by patient (not recommended by surgeon), patient does not follow surgeon instructions, patient over exerts.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 48
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7702659
• Report Number: 0009617544-2018-00177
• Device Sequence Number: 2771467
• Product Code: KWQ
• UDI-Device Identifier: 07613252152606
• UDI-Public: 07613252152606
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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: No Information
• Device Catalogue Number: 48811348
• Device Lot Number: 164097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 10/19/2018
• 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