MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 26; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	48811226
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	07/31/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; screw backed out at bottom level and wing was broken and screw starting to back out on top level.Patient required revision and was sent to ent to see if there was any damage to the esophagus.
Additional Manufacturer Narrative
Method: risk assessment.Results: visual inspection, functional inspection, and manufacturing files were not reviewed because no lot or parts were provided.The patient's bmi (body mass index) was calculated as 32.6, indicating the weight is in the obese category for adults this height.Conclusion: patient's bmi (body mass index) was calculated as 32.6, indicating the weight is in the obese category for adults this height, so this is the probable root cause of the screw backout and locking mechanism fracture as per the statement in the ifu "surgeons must instruct patients in detail about the limitations of the implants, including, but not limited to, the impact of excessive loading through patient weight or activity".
Event or Problem Description
It was reported that; screw backed out at bottom level and wing was broken and screw starting to back out on top level.Patient required revision and was sent to ent to see if there was any damage to the esophagus.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 26
• 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: 6824046
• Report Number: 0009617544-2017-00335
• Device Sequence Number: 898447
• Product Code: KWQ
• UDI-Device Identifier: 07613252152170
• UDI-Public: (01)07613252152170
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: 48811226
• Device Catalogue Number: 48811226
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 10/27/2017
• 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: Other; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 100