MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 14; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48811114
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they were doing an acdf with plating and that when placing the screws into the plate, the silver locking wing on the plate appeared to deform.The surgeon did not want to continue using this particular plate, so swapped it for a new one of the same size and make.Update: the surgeon further reported that he put the screw in and then wanted to reposition it.When he tried to remove the screw, it had gone past the locking mechanism and broke as it was taken out.He said he broke the wing on the plate.The screw did not break.
Additional Manufacturer Narrative
Method: vidual inspection, device history review, complaint history review, risk assessment; result: the device was confirmed visually to have a deformed spring bar.Manufacturing files were reviewed and no anomalies were found.Conclusion: the probable root cause of the mechanism popping up is not determined and multifactorial.
Event or Problem Description
It was reported that they were doing an acdf with plating and that when placing the screws into the plate, the silver locking wing on the plate appeared to deform.The surgeon did not want to continue using this particular plate, so swapped it for a new one of the same size and make.Update: the surgeon further reported that he put the screw in and then wanted to reposition it.When he tried to remove the screw, it had gone past the locking mechanism and broke as it was taken out.He said he broke the wing on the plate.The screw did not break.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 14
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6120193
• Report Number: 0009617544-2016-00473
• Device Sequence Number: 13765322
• Product Code: KWQ
• UDI-Device Identifier: 07613252152118
• UDI-Public: (01)07613252152118
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K083562
• 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): 01/23/2017

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: No Information
• Device Catalogue Number: 48811114
• Device Lot Number: 168528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2016
• Supplement Report FDA Received Date: 01/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1