BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNFRAME RING CLAMP

    MDR report key: 2944956 · Received February 1, 2013

    Report

    Report Number
    8030965-2013-10015
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS REC'D WITH NO VISIBLE DAMAGES. A FUNCTION TEST ACCORDING TO THE TEST INSTRUCTION WAS MADE AND THE CLAMPS WERE CHECKED. NO DISCREPANCY TO THE SPECIFICATION WAS FOUND; IT WAS POSSIBLE TO ATTACH THE CLAMPS AND THEY DID HOLD AS REQUIRED. NO MFG RELATED FAULT COULD BE DETECTED. THE MFG RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DURING AN ALIF PROCEDURE, ASSISTANT SURGEON AND NEURO SURGEON HAD DIFFICULTY USING THE SYNFRAME RING CALM TO ATTACH TO THE RETRACTOR RING. THE RING CLAMP BEGAN TO SLIP AND NOT HOLD IN PLACE. THE ASSISTANT SURGEON AND NEURO SURGEON USED EIGHT DIFFERENT SYNFRAME RING CLAMPS AND HAD DIFFICULTY WITH ALL EIGHT OF THEM. THE PROCEDURE WAS COMPLETED AND NO HARM TO THE PT. THE PROCEDURE TOOK AND ADDITIONAL 10 TO 15 MINUTES TO COMPLETE. THIS IS 6 OF 8 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44933 SYNFRAME RING CLAMP LXH SYNTHES GMBH 3512720

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR