MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR VARIABLE SELF DRILLING SCREW 4X12MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48824012
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	06/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; screws backed through the locking mechanism into the patient's vocal chords.
Additional Manufacturer Narrative
Lot# yrk.Manufacturing files were reviewed and no anomalies were found.Visual inspection of the returned two screws revealed no anomalies.The plate remains implanted.Per the ifu "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." and "the surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device may need to be replaced in the future.The rep was unaware of the patients lifestyle or any other details of the original surgery.Conclusion: the root cause is not determined due to lack of information.
Event or Problem Description
It was reported that; screws backed through the locking mechanism into the patients vocal chords.

• Brand Name: AVIATOR VARIABLE SELF DRILLING SCREW 4X12MM
• 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: 5783600
• Report Number: 0009617544-2016-00279
• Device Sequence Number: 587394
• Product Code: KWQ
• UDI-Device Identifier: 07613252152590
• UDI-Public: (01)07613252152590
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2016

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: 48824012
• Device Lot Number: YRK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2016
• Supplement Report FDA Received Date: 09/28/2016
• 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