BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT 5.25 OCCIPITAL BONE, SCREW, 8MM

    MDR report key: 726175 · Received June 15, 2006

    Report

    Report Number
    1526439-2006-00141
    Event Type
    Injury
    Date Received
    June 15, 2006
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    HWC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE CONCLUSIONS CAN BE MADE AT THIS TIME. THERE IS NO CONNECTION THAT CAN BE MADE BETWEEN THE REPORTED EVENTS AND ANY SHORTCOMING OF THE DEPUY SPINE PRODUCTS AT THIS TIME. THE SUMMIT SI OCCIPITAL FIXATION SYSTEM IS TECHNIQUE SENSITIVE. PATIENT SELECTION AS WELL AS USE OF THE PROPER SYSTEM HARDWARE TO BUILD THE CONSTRUCT IS CRITICAL TO ACHIEVING STABLE FIXATION. SCREW BACK OUT / LOOSENING ARE LISTED AS POSSIBLE ADVERTISE OUTCOMES IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE.

    Description of Event or Problem · 1

    ON 1/11 , O-C2-C4 INSTRUMENTATION WAS DONE. THREE MONTHS LATER BOTH THE SCREWS WERE FOUND BACKING OUT. AND RE-OPERATION WAS CONSIDERED. ON 4/17 RE-OPERATION WAS DONE WITH 1746-11-509 AND 1748-11-511 AND WITH POLYETHYLENE BRAIDED CABLE FIXATION. CURING BOTH THE OPERATIONS, THE SCRWS WERE FELT SECURELY INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT 5.25 OCCIPITAL BONE, SCREW, 8MM FIXATION DEVICE HWC DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention LOT UNK| SUMMIT SCREW 174611410