MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR VARIABLE SELF DRILLING SCREW 4X14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48824014
Medical Device Problem Code	Migration (4003)
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.
Additional Manufacturer Narrative
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 screw shave no anomalies associated.Manufacturing files were reviewed and no anomalies were found.The exact root cause cannot be determined.The locking mechanism of the screw is on the plate.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.
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.

• Brand Name: AVIATOR VARIABLE SELF DRILLING SCREW 4X14MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7714231
• Report Number: 0009617544-2018-00179
• Device Sequence Number: 1107808
• 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: 48824014
• Device Lot Number: WE9
• 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: 09/28/2018
• Initial Report FDA Received Date: 07/24/2018
• 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