BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1923411 · Received December 13, 2010

    Report

    Report Number
    1030489-2010-01586
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION CONFIRMS THE SUPERIOR TANG IS BROKEN; THE BROKEN PIECE IS MISSING, AND NOT RETURNED FOR ANALYSIS. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE REVEALS A FAIRLY BRITTLE FRACTURE, WITH NO INDICATION OF FATIGUE. FRACTURE INITIATION APPEARS TO BE LOCATED AT THE BASE OF THE TANG, CONSISTENT WITH BEND STRESS OVERLOAD. THE NATURE AND LOCATION OF THE FRACTURE SURFACE IS CONSISTENT WITH FAILURE DUE TO INSUFFICIENT VERTEBRAL ENDPLATE PREPARATION, RESULTING IN EXCESSIVE ROTATIONAL FORCE DURING IMPLANTATION. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE GUIDE TIPS BROKE OFF OF THE IMPLANT INSERTER. NO PATIENTCOMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX WARSAW ORTHOPEDIC, INC. NA MC04L001

    Patients

    Seq Age Sex Outcome Treatment
    1