MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY THREE LEVEL PLATE SIZE 45; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48811345
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon informed rep that wing of aviator plate protruding outward.Surgeon used coker instrument to break off wing.
Additional Manufacturer Narrative
Results: device inspection, device history review, and complaint history review could not be performed, as the device was remains implanted.Conclusion: the root cause is undetermined.
Event or Problem Description
It was reported that; surgeon informed rep that wing of aviator plate protruding outward.Surgeon used coker instrument to break off wing.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 45
• 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: 5829174
• Report Number: 0009617544-2016-00311
• Device Sequence Number: 326328
• Product Code: KWQ
• UDI-Device Identifier: 07613252152286
• UDI-Public: (01)07613252152286
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• 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): 07/06/2016

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: 48811345
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2016
• Supplement Report FDA Received Date: 10/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1