BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREMER CROWN W/ HIFIX SKULL PINS

    MDR report key: 1707968 · Received May 28, 2010

    Report

    Report Number
    1526439-2010-00079
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Date of Event
    May 20, 2010
    Manufacturer
    DEPUY SPINE INC
    Product Code
    JEC
    PMA / PMN Number
    K915800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CROWN WAS RETURNED WITH VEST CONNECTING BOLT BENT AND BROKEN OFF WITHIN THE CROWN. IT APPEARS THAT THE USER LIKELY THREAD THE BOLT DURING INSERTION. AS REPORTED THE BOLT WAS ADVANCED FURTHER WHEN RESISTANCE WAS FELT CAUSING IT TO BIND. THE ADDITIONAL APPLICATION OF A TYPICAL FORCE RESULTED IN THE BOLT BREAKING. THE THREADED INSERTION HOLES ARE INSPECTED DURING MANUFACTURE TO ENSURE THAT THE THREADS CONFORM TO SPECIFICATION.

    Description of Event or Problem · 1

    DOCTOR WAS PLACING A LARGE HALO AND AIRFLO VEST. WHEN INSERTING ONE OF THE CRANIAL PINS HE NOTICED THAT IT BECAME DIFFICULT TO THREAD INTO THE CROEN. AS IF IT WAS MIS-THREAD. AFTER TRYING TO CONTINUE TO ADVANCE THE PIN, THE HEAD OF THE BOLT SHEARED OFF. AS A RESULT OF THIS EVENT, THIS WAS A SIGNIFICANT DELAY AND THE ANOTHER CROWN HAD TO BE PLACED ON THE PT THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREMER CROWN W/ HIFIX SKULL PINS HALO CROWN JEC DEPUY SPINE INC NA 060871

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK