MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 32; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48811232
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Per reported event; surgeon attempted to implant a 32mm 2 level plate with 4.35mm rescue screws and the metal locking hinge came disconnected from the plate.Surgeon took plate out and inserted a new one.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; manufacturing files were reviewed and no anomalies were found.Causes of the spring bar popping out include cantilever the guide during removal from plate and bending the plate over the locking mechanisms the stryker rep reported that the variable drill guide was used to prepare the screw holes and that the plate may have been bent over the holes.Probable root cause of the mechanism popping up is not determined.
Event or Problem Description
Per reported event; surgeon attempted to implant a 32mm 2 level plate with 4.35mm rescue screws and the metal locking hinge came disconnected from the plate.Surgeon took plate out and inserted a new one.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 32
• 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: 5804237
• Report Number: 0009617544-2016-00292
• Device Sequence Number: 446686
• Product Code: KWQ
• UDI-Device Identifier: 07613252152200
• UDI-Public: (01)07613252152200
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2016

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: 48811232
• Device Lot Number: 156931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2016
• Supplement Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1