BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL BODY SPREADER- ANGLED

    MDR report key: 2962850 · Received February 14, 2013

    Report

    Report Number
    8030965-2013-10200
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE PRODUCT EVALUATION REVEALED THAT THE PIVOT SCREW THAT HOLDS THE LOCKING MECHANISM TO THE HANDLE IS MISSING. THE LOCKING MECHANISM IS LOOSE AND WILL NO LONGER HOLD THE ARMS IN A SET POSITION. THE THREADED HOLE THAT THE SCREW WAS IN HAS SIGNS THAT A SPOT WELD WAS PERFORMED AT THE TOP OF IT AND WAS BROKEN. THE THREADS ON THAT HOLE APPEAR INTACT AND IN GOOD CONDITION. THERE ARE WEAR MARKS ON THE TEETH OF THE LOCKING MECHANISM THAT INDICATE THAT THE INSTRUMENT HAS BEEN SUCCESSFULLY USED IN THE FIELD WITH THE PIN IN PLACE. THE INSTRUMENT ALSO HAS SLIGHT DENT MARKS ON THE TOP OF THE HANDLE INDICATING IT WAS IMPACTED ON DURING USE. IT IS CONCLUDED THAT WITH THE LIMITED AMOUNT OF INFORMATION IN THE COMPLAINT DESCRIPTION, AND THE SCREW NOT BEING RETURNED FOR EVALUATION MAKES IT DIFFICULT TO DETERMINE THE EXACT FAILURE MODE IN THIS CASE. THE COMPLAINT IS DEEMED INDETERMINATE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL INFORMATION: THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE EVALUATION FOUND THE RATCHET SPINDLE DETACHED FROM THE HANDLE ALTHOUGH SECURED WITH A LASER WELD. THE SPREADER CORRESPONDED TO THE DRAWING AND PROCESSES AT THE TIME OF MANUFACTURE. THE EVALUATION FOUND THAT TOO MUCH FORCE WAS APPLIED TO THE WELD CAUSING IT TO THE BREAK IT AND RELEASING THE RETAINING SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE AT LEVELS L4-S1, THE SCREW ON THE LOCKING MECHANISM BROKE OFF THE DISTRACTOR. THE SCREW DID NOT BREAK INTO THE WOUND. THERE WAS NOTHING TO RETRIEVE FROM THE PATIENT. THE SURGEON USED ANOTHER DISTRACTOR TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64806 VERTEBRAL BODY SPREADER- ANGLED HTD SYNTHES GMBH A7OA46

    Patients

    Seq Age Sex Outcome Treatment
    1