MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY THREE LEVEL PLATE SIZE 54; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48811354
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screws were inserted and engarded with late at all levels without incident.Upon final cam lock tightening it was noticed by the surgeon that the spring bar had deform unilaterally at two separate levels.Sling bar did not translate and was bent / pinched under the screw lip.This made the plate unable to lock at all levels.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: manufacturing files were reviewed and no anomalies were found.It appears that the surgical technique was followed.Conclusion: the probable root cause is not determined.
Event or Problem Description
It was reported that the screws were inserted and engarded with late at all levels without incident.Upon final cam lock tightening it was noticed by the surgeon that the spring bar had deform unilaterally at two separate levels.Sling bar did not translate and was bent / pinched under the screw lip.This made the plate unable to lock at all levels.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 54
• 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: 5514728
• Report Number: 0009617544-2016-00125
• Device Sequence Number: 18928914
• Product Code: KWQ
• UDI-Device Identifier: 07613252152316
• UDI-Public: (01)07613252152316
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K083562
• 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): 03/01/2016

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: 48811354
• Device Lot Number: 14J093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2016
• Supplement Report FDA Received Date: 06/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR