BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT 4.5MM OCCIPITAL BONE SCREW, 10MM

    MDR report key: 1011291 · Received March 11, 2008

    Report

    Report Number
    1526439-2008-00063
    Event Type
    Injury
    Date Received
    March 11, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    HWC
    PMA / PMN Number
    K002733
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DISCREPANCIES. THE PROCESS OF FIXATION IS SURGEON TECHNIQUE SENSITIVE. NO DEFINITIVE CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    CONTACT IN ANOTHER COUNTRY, REPORTED THAT A PATIENT HAD O-C4 INSTRUMENTATION WAS DONE WITH SUMMIT SI SYSTEM IN 2008. AFTER THE SURGERY, THE SCREW WAS FOUND BACKING OUT. THERE IS NO PLAN TO REVISE AT THIS TIME. PATIENT WAS PLACED IN A HALO CROWN AND VEST. AS THIS COULD RESULT IN THE NEED FOR SURGICAL INTERVENTION AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT 4.5MM OCCIPITAL BONE SCREW, 10MM FIXATION DEVICE HWC DEPUY SPINE, INC. NA 4926N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention