BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED CANCELLOUS BONE SCREW

    MDR report key: 1410258 · Received July 6, 2009

    Report

    Report Number
    3025141-2009-00016
    Event Type
    Injury
    Date Received
    July 6, 2009
    Date of Event
    May 5, 2009
    Report Date
    June 10, 2009
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    PMA / PMN Number
    K942341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER COULD NOT CONFIRM THE EXACT MODEL. THE FOLLOWING SCREWS WERE IMPLANTED DURING THE INITIAL SURGERY. THE MIGRATED SCREW IS ONE OF THE FOLLOWING: MODEL # HCA5500-S; LOT # W63957; MFR DATE: 06/2008; EXP DATE: 06/2015; MODEL # HCA5340-S, LOT # W63565, MFR DATE: 06/2008, EXP DATE: 06/2015; MODEL # HCA5345-S, LOT # W73152, MFR DATE: 12/2008, EXP DATE: 12/2015. A REVIEW OF THE PT'S X-RAYS REVEALED THAT THE POLARUS CAP WAS NOT USED TO LOCK THE SCREW IN PLACE. THERE IS NOT A CAP VISIBLE IN ANY OF THE X-RAYS SENT. THE SURGICAL TECHNIQUE STATES: "PLACE THE CAP ASSEMBLY ONTO THE 3.5 MM DRIVER AND INSERT INTO THE TOP OF THE ROD. ADVANCE THE CAP UNTIL THE POLYETHYLENE FULLY ENGAGES THE THREADS OF THE MOST PROXIMAL CANCELLOUS SCREW HOLDING IT INTO POSITION." IMPROPER TECHNIQUE OR UNFAMILIARITY WITH THE IMPLANTS AND TECHNIQUE MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    AT AN UNK TIME POST PLACEMENT OF AN ACUMED CANCELLOUS LOCKING SCREW, THE SCREW MIGRATED. IN 2009, THE MIGRATED SCREW WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED CANCELLOUS BONE SCREW SCREW, FIXATION, BONE HWC ACUMED LLC HCA - UNK SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention