MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 14; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	48811114
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; aviator plate was removed due to broken locking mechanism.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, labelling review, risk assessment.The reported event was confirmed via communication with the sales representative.The reported event of a securing mechanism fracture was confirmed via visual inspection.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Per further correspondence, it was reported that the patient had fused.Because the patient fused, the device performed as it was intended per the surgical technique "stryker spine devices are indicated for treatment of fracture or stabilization of a surgical site during the normal bone consolidation process.After this period, the presence of the device is no longer strictly required and its removal can be planned".The likely cause of the reported event was determined to be normal wear.
Event or Problem Description
It was reported that; aviator plate was removed due to broken locking mechanism.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 14
• 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: 7180284
• Report Number: 0009617544-2018-00004
• Device Sequence Number: 13788742
• Product Code: KWQ
• UDI-Device Identifier: 07613252152118
• UDI-Public: (01)07613252152118
• 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 Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

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: 48811114
• Device Catalogue Number: 48811114
• Device Lot Number: 119639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 04/27/2018
• 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