MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 34; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	48811234
Medical Device Problem Codes	Fracture (1260); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	09/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: plate removal update 09/06/2017: post-op x-ray showed a screw backing out.
Additional Manufacturer Narrative
Method: risk assessment; result: the plate was confirmed to have a fractured locking mechanism post op via correspondence with the sales representative and revision surgery.The implants were discarded.Manufacturing files were not reviewed because no lot numbers were provided.The patient's bone quality was described as poor but it was reported that fusion was believed to have been achieved.The likely root cause is the patient's poor bone quality.
Event or Problem Description
It was reported that: plate removal.Update 09/06/2017: post-op x-ray showed a screw backing out.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 34
• 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: 6904838
• Report Number: 0009617544-2017-00370
• Device Sequence Number: 1181968
• Product Code: KWQ
• UDI-Device Identifier: 07613252152217
• UDI-Public: (01)07613252152217
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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 Model Number: 48811234
• Device Catalogue Number: 48811234
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 02/24/2018
• 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: 78 YR