MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY THREE LEVEL PLATE SIZE 42; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48811342
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	05/04/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient went in for a chest x-ray and they noticed that 2 screws had backed out.Patient had to have revision surgery.
Additional Manufacturer Narrative
Method: complaint history review; risk assessment; results: manufacturing files could not be reviewed due to lack of parts.The stryker rep did not report the possible reasons for the backout and did not respond to any further communication to clarify the event.Conclusion: the root cause is not determined due to lack of information and returned parts.
Event or Problem Description
It was reported that patient went in for a chest x-ray and they noticed that 2 screws had backed out.Patient had to have revision surgery.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 42
• 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: 5721480
• Report Number: 0009617544-2016-00225
• Device Sequence Number: 174522
• Product Code: KWQ
• UDI-Device Identifier: 07613252152279
• UDI-Public: (01)07613252152279
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48811342
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2016
• Supplement Report FDA Received Date: 09/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR