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

Catalog Number 48824012

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 06/13/2016

Event Type  Injury  

Event Description

It was reported that; screws backed through the locking mechanism into the patient's vocal chords.

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 Description

It was reported that; screws backed through the locking mechanism into the patients vocal chords.

• Brand Name: AVIATOR VARIABLE SELF DRILLING SCREW 4X12MM
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5783600
• MDR Text Key: 49202766
• Report Number: 0009617544-2016-00279
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152590
• UDI-Public: (01)07613252152590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention