MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 18; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48811118
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	03/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; 18mm plate was implanted & when trying to tighten screws down surgeon was unable to get pass spring bar.End was bent not allowing screw to engage.Plate was removed and new selected with rescue screw used.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The device was not confirmed to have a deformed spring bar and functional testing revealed a blocker able to be turned.Manufacturing files were reviewed and no anomalies were found.Potential root causes include:-surgeon does not tighten screws properly; - screw hole not properly prepared (too shallow).
Event or Problem Description
It was reported that; 18mm plate was implanted & when trying to tighten screws down surgeon was unable to get pass spring bar.End was bent not allowing screw to engage.Plate was removed and new selected with rescue screw used.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 18
• 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: 6455178
• Report Number: 0009617544-2017-00118
• Device Sequence Number: 563602
• Product Code: KWQ
• UDI-Device Identifier: 07613252152132
• UDI-Public: (01)07613252152132
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• 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): 06/01/2017

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: 48811118
• Device Lot Number: 160809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1