BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD CRANIOTOME, BM

    MDR report key: 3984187 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16385
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    February 21, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFF
    PMA / PMN Number
    K974025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND EVALUATED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS CURRENTLY IN PROCESS. WHEN THE EVALUATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA STATING THAT THE DEVICE DID NOT FUNCTION. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663926 STD CRANIOTOME, BM GFF DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1