BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI PRE-BENT ROD 240MM 110DEG

    MDR report key: 2860734 · Received December 6, 2012

    Report

    Report Number
    8030965-2012-01488
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWP
    PMA / PMN Number
    K090549
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, PATIENT WAS IMPLANTED WITH AN OCCIPITAL PLATE, TWO RODS AND TWO SCREWS. LESS THAN ONE WEEK POST-OPERATIVE, PATIENT UNDERWENT REVISION DUE TO A ROD PULLING OUT OF THE OCCIPITAL PLATE. THE SURGEON SPECULATES THE ROD MAY HAVE BEEN CUT TOO SHORT OR THAT THE CABLING USED TO HOLD THE GRAFT IN PLACE (FROM ROD TO ROD) MAY HAVE CAUSED ADDED STRESS. THE PATIENT HAD NOT BEEN DISCHARGED FROM THE HOSPITAL FOLLOWING INITIAL PROCEDURE. BEFORE DISCHARGE, PATIENT RECEIVED LATERAL X-RAY SHOWING THE ROD PULLED THROUGH FROM THE PLACEMENT AREA. THE SURGEON REVISED WITH THE SAME PARTS, WITH THE EXCEPTION OF ONE ROD, WHICH WAS EXPLANTED (THE EXPLANTED ROD WAS THE ONE THE SURGEON BELIEVED WAS TOO SHORT), AND REPLACED. THIS IS 2 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM TI PRE-BENT ROD 240MM 110DEG PRE-BENT ROD KWP SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OCCIPITAL PLATE X 1ROD X 1SCREW X 2