BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME HALF RING

    MDR report key: 3003552 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10410
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    November 4, 2010
    Report Date
    February 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. THE DHR WAS REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE HEXAGONAL RECESS OF THE SET SCREWS IS COMPLETELY WORN OUT AND THE THREAD IS DAMAGED. THE PRODUCT INVESTIGATION REVEALED THAT THERE WERE NO MANUFACTURING RELATED FAULTS THAT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ALIF, L5 - S1 PROCEDURE, THE SYNFRAME HOLDING RING WAS SLIPPING AS THE SCREW WAS SLIPPING. IN THE SAME PROCEDURE THE SCREW ON TOP OF THE SYNFRAME GUIDE ROD WAS ALSO STRIPPING AND SLIPPING. THE SURGEON MANAGED TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87170 SYNFRAME HALF RING LXH SYNTHES GMBH 1928921

    Patients

    Seq Age Sex Outcome Treatment
    1