BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT 5.25 OCCIPITAL BONE SCREW, 11MM

    MDR report key: 726142 · Received June 15, 2006

    Report

    Report Number
    1526439-2006-00138
    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 DIFINITE 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 ADVERSE OUTCOMES IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE.

    Description of Event or Problem · 1

    TWO WEEKS POST-OP ONE OCCIPITAL SCREW WAS FOUND ON X-RAY TO HAVE BACKED/ PULLED OUT. THE PATIENT IS UNDER CLOSE WATCH FOR POSSIBLE RE-OPERATION. AS SURGICAL INTERVENTION MAY OCCUR AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT 5.25 OCCIPITAL BONE SCREW, 11MM FIXATION DEVICE HWC DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention