BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1912554 · Received December 2, 2010

    Report

    Report Number
    1030489-2010-01515
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MQP
    PMA / PMN Number
    K052261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VB REPLACEMENT IMPLANT, IMPLANT DATE: (B)(6) 2010. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. A REVIEW OF DEVICE HISTORY RECORDS IS NOT POSSIBLE AT THIS TIME WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL PROCEDURE TO IMPLANT A PEEK IMPLANT, THE IMPLANT INSERTER LOOSENED WHEN IT WAS IMPACTED WITH A MALLET. WHEN THE INSERTER LOOSENED, THE IMPLANT DETACHED EARLY FROM THE INSERTER. THE IMPLANT WAS ABLE TO BE IMPLANTED IN A GOOD POSITION THIS TIME. NO PATIENT COMPLICATIONS WERE REPORTED IN THIS CASE. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1