MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 32; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48811232
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; plate was bent and implanted into the patient.After surgeon took an xray and upon closing, surgeon noticed the silver locking mechanism was deformed.Took the plate out and replaced with the same size plate.
Additional Manufacturer Narrative
Lot# 157856.Method: visual inspection;device history review; complaint history review; risk assessment.Results: the device was confirmed to have a deformed spring bar resulting in a ten minute delay in surgery.Manufacturing files were reviewed and no anomalies were found.Conclusion: the stryker rep confirmed that no drill guides were used to prepare the screw holes and no revision driver was used to remove the screw for repositioning, so the cause is not using the recommended drill guides and revision drivers as per the stg.
Event or Problem Description
It was reported that; plate was bent and implanted into the patient.After surgeon took an xray and upon closing, surgeon noticed the silver locking mechanism was deformed.Took the plate out and replaced with the same size plate.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 32
• 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: 5673191
• Report Number: 0009617544-2016-00202
• Device Sequence Number: 10810429
• Product Code: KWQ
• UDI-Device Identifier: 07613252152200
• UDI-Public: (01)07613252152200
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2016

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: 48811232
• Device Lot Number: 157856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2016
• Supplement Report FDA Received Date: 08/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1