MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 12; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48811112
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	04/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a plate that was implanted on (b)(6) 2015 because one of the screws was backing out.
Additional Manufacturer Narrative
Method: complaint history review; risk assessment.Results: manufacturing files were not reviewed because no parts or lot numbers were available.The stryker rep confirmed that the holes were not prepared with the drill guide and were freehanded.The stryker rep also reported that the patient was a smoker with poor bone quality.Conclusion: the likely root cause is not preparing the holes (i.E.Using the drill guide) as specified in the surgical technique and the patient's lifestyle (smoking) as specified in the ifu.
Event or Problem Description
It was reported that a plate that was implanted on (b)(6) 2015 because one of the screws was backing out.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 12
• 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: 5661429
• Report Number: 0009617544-2016-00191
• Device Sequence Number: 16208398
• Product Code: KWQ
• UDI-Device Identifier: 07613252152101
• UDI-Public: (01)07613252152101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2016

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: 48811112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2016
• Supplement Report FDA Received Date: 07/22/2016
• 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