BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1981860 · Received February 8, 2011

    Report

    Report Number
    1030489-2011-00101
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBE WAS RETURNED FOR EVALUATION. APPROXIMATELY ~36MM OF TIP HAS BEEN BROKEN OFF AND NOT RETURNED FOR ANALYSIS. FRACTURE ANALYSIS REVEALS A FAIRLY FLAT, BRITTLE FRACTURE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PROBE BECAME STUCK IN HARD BONE AND THE TIP BROKE OFF WHILE BEING PULLED OUT. THE TIP WAS NOT RETRIEVED FROM THE PATIENT'S BONE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT PROBE HXB WARSAW ORTHOPEDIC, INC NA PT11778

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention