BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1934620 · Received December 21, 2010

    Report

    Report Number
    1030489-2010-01619
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE "DOVETAIL" PORTION OF THE DISTAL TIP IS TOO SMALL BY APPROXIMATELY 4MM. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE REVEALED THAT REWORK WAS PERFORMED ON THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTRACTION OF THE CHISELS FROM THE PATIENT WAS NOT POSSIBLE WITH THE INSTRUMENT REMOVER. THE CHISELS WERE EVENTUALLY REMOVED WITH PAIN TO THE PATIENT, LOSS OF TIME, AND LATERAL OSCILLATION OF THE DEVICE. PER THE HEALTH CARE PROFESSIONAL, THIS COULD LEAD TO A LOSS OF PRESS-FIT EFFECT ON THE KEEL OF THE INTERBODY DEVICE IMPLANTED. THE STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WARSAW ORTHOPEDIC, INC. NA IM05G0771

    Patients

    Seq Age Sex Outcome Treatment
    1 Other