MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 28; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48811228
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; two 28mm anterior cervical plates had the locking mechanism brake during screw insertion.The third 28mm plate was inserted successfully.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; manufacturing files were reviewed and no anomalies were found.The probable root cause of the mechanism popping up is not determined and multifactoral.
Event or Problem Description
It was reported that; two 28mm anterior cervical plates had the locking mechanism brake during screw insertion.The third 28mm plate was inserted successfully.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 28
• 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: 5999336
• Report Number: 0009617544-2016-00400
• Device Sequence Number: 18930279
• Product Code: KWQ
• UDI-Device Identifier: 07613252152187
• UDI-Public: (01)07613252152187
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48811228
• Device Lot Number: 164142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2016
• Supplement Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1