BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEO-LOCK

    MDR report key: 7893417 · Received September 20, 2018

    Report

    Report Number
    3005168462-2018-00001
    Event Type
    Malfunction
    Date Received
    September 20, 2018
    Report Date
    September 19, 2018
    Manufacturer
    BACTERIN INTERNATIONAL, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED THAT AN INSERTER WAS BROKEN AND REQUESTED REPLACEMENT OF THE INSTRUMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS. THE COMPLAINANT LATER REPORTED THAT THE FACET DOWEL INSERTER BROKE DURING INSERTION. A SECOND INSERTER WAS USED AND WAS NOT HOLDING THE DOWEL APPROPRIATELY. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY USING A THIRD INSERTER. THE COMPLAINANT CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS. THE INSERTER WAS EVALUATED BY THE MANUFACTURER. THE INSTRUMENT WAS AS DESCRIBED BY THE COMPLAINANT, THE COLLET WAS BROKEN OFF OF THE COLLET ROD. THE BREAK APPEARED TO BE FROM A FAILED WELD THAT CONNECTED THE COLLET AND COLLET ROD. THE SECOND INSERTER HAD BENT COLLET, PREVENTING IT FROM FUNCTIONING AS INTENDED. IT IS UNKNOWN HOW THE SECOND INSERTER WAS DAMAGED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT AN INSERTER WAS BROKEN AND REQUESTED REPLACEMENT OF THE INSTRUMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737397 OSTEO-LOCK FACET DOWEL INSERTER LXH BACTERIN INTERNATIONAL, INC. 6027 062811

    Patients

    Seq Age Sex Outcome Treatment
    1 Other