BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2M

    MDR report key: 2852123 · Received November 14, 2012

    Report

    Report Number
    8010177-2012-00253
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 19, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON INSERTED REPOSITIONING PIN INTO THE PT'S MANDIBLE, THE THREADED END DISLOCATED AND REMAINED IN THE MANDIBLE. THE DISLOCATED PART WAS IN THE PT'S SKULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2M INSTRUMENT LXH STRYKER OSTEOSYNTHESIS FREIBURG NA V8

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK