MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE

Catalog Number	656416
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "variax screws locked into the plate and would not come out" and "needed to completely remove our product and put a different product in".
Event or Problem Description
As reported: "variax screws locked into the plate and would not come out" and "needed to completely remove our product and put a different product in".
Additional Manufacturer Narrative
Investigation of the returned device revealed the subject product to be a concomitant item.The device did not contribute to the reported event.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• Brand Name: BONE SCREW, T8 FULL THREAD, 2.7MM/L16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8889995
• Report Number: 0008031020-2019-01045
• Device Sequence Number: 11374571
• Product Code: HWC
• UDI-Device Identifier: 07613327068672
• UDI-Public: 07613327068672
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 656416
• Device Lot Number: 1000276676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1