MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 24; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Model Number	48811224
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the locking mechanism would not lock on one side.
Additional Manufacturer Narrative
The device was left implanted, therefore inspection of the product was not completed.Product and complaint history reviews were not completed as a lot number could not be obtained.The surgical technique guide states in regards to screw hole preparation that the "use of the screw hole preparation instruments including the fixed or variable drill guides, all-in-one drill guides or punch awl with sleeves is required to place screws in the proper trajectory, help prevent difficulty locking the blocker".The probable root cause of the event is over angulating the screws.
Event or Problem Description
It was reported that the locking mechanism would not lock on one side.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 24
• 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: 7070752
• Report Number: 0009617544-2017-00428
• Device Sequence Number: 10978962
• Product Code: KWQ
• UDI-Device Identifier: 07613252152163
• UDI-Public: (01)07613252152163
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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 Model Number: 48811224
• Device Catalogue Number: 48811224
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR