BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL BODY SPREADER- ANGLED

    MDR report key: 3012544 · Received March 20, 2013

    Report

    Report Number
    8030965-2013-10559
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    April 18, 2012
    Report Date
    April 18, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND THE RATCHET SPINDLE WAS NO LONGER ATTACHED TO THE HANDLE, ALTHOUGH IT WAS SECURED WITH A LASER WELD. THE SPREADER CORRESPONDED TO THE DRAWING AND PROCESSES AT THE TIME OF MANUFACTURE. IT WAS CONCLUDED THAT TOO MUCH FORCE WAS APPLIED TO THE WELD, CAUSING IT TO BREAK AND RELEASE THE SCREW. THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STANDPOINT.

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2012.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SYNFIX PROCEDURE AT L5-S1, THE SURGEON WAS DISTRACTING THE VERTEBRAL BODY USING THE VERTEBRAL BODY SPREADER AND THE PIN IN THE SPREADER FELL OUT. THE PIN WAS RETRIEVED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116139 VERTEBRAL BODY SPREADER- ANGLED HTD SYNTHES GMBH A7 PA 02

    Patients

    Seq Age Sex Outcome Treatment
    1