BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACFIX ROD BENDER (2 HAND)

    MDR report key: 5857515 · Received August 9, 2016

    Report

    Report Number
    0002184052-2016-00158
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    July 12, 2016
    Report Date
    July 12, 2016
    Manufacturer
    ZIMMER SPINE
    Product Code
    HXW
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODE IS HXP (NOT AVAILABLE ON DROP DOWN LIST). WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REPORT THREE OF THREE FOR THE SAME EVENT; SEE ALSO 0002184052-2016-00156 AND 00157.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, WHILE INSERTING THE 5.5 SCREW, THE SCREW HEAD GOT DIS-MANTLED FROM THE BODY. THE SCREW BROKE WHILE LOADING IT ON THE DRIVER. THEREFORE, ANOTHER SCREW WAS USED. IN ADDITION, THE POWER KNOB REDUCER GOT STUCK DURING THE SURGERY AND WAS NOT USABLE. AND, THE ROD BENDER WAS NOT IN THE PART OF THE SET AND SHOULD HAVE BEEN. IT WAS CONFIRMED THERE WAS A SURGICAL DELAY LONGER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509620 BACFIX ROD BENDER (2 HAND) ROD BENDER HXW ZIMMER SPINE N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R