BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN CRANIOTOMY KIT

    MDR report key: 1150496 · Received September 5, 2008

    Report

    Report Number
    1226348-2008-00228
    Event Type
    Injury
    Date Received
    September 5, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBF
    PMA / PMN Number
    K933894
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED, A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND, THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT HE CRANIOBLADE GOT BLOCKED IN THE BONE DURING THE CRANIOTOMY (WHICH TAKES MORE THAN 2 MINUTES). THE DURA MATTER WAS DAMAGED AND STITCHED UP. NO OTHER CLINICAL CONSEQUENCE WERE REPORTED. NO PRODUCT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN CRANIOTOMY KIT DRILLS, BURRS, TREPHINES & ACCESSORIES HBF CODMAN & SHURTLEFF, INC. NA DA883

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention