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

Model Number	48811224
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor attempted to use a 2 level plate on friday and as he was advancing the first screw, the locking wing would not allow it to pass and bent downward with the screw.He was not over angulating the screw and we made sure the wings were in the unlock position.It was a c5-7 acdf.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, material analysis; risk assessment; result: the reported event was confirmed by visual inspection to have a locking mechanism deformed.The plate was exchanged for a new one without delay.Manufacturing files were reviewed and no anomalies were found.Potential causes may be: user tilts guide off axis affecting screw path.Over-angulation of screwdriver which leads to unintended cantilever force.Guide not properly attached to plate.
Event or Problem Description
It was reported that the doctor attempted to use a 2 level plate on friday and as he was advancing the first screw, the locking wing would not allow it to pass and bent downward with the screw.He was not over angulating the screw and we made sure the wings were in the unlock position.It was a c5-7 acdf.

• 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: 7223077
• Report Number: 0009617544-2018-00021
• Device Sequence Number: 1174833
• Product Code: KWQ
• UDI-Device Identifier: 07613252152163
• UDI-Public: (01)07613252152163
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K083562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• 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: 140083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 01/01/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 01/26/2018
• 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