BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.0 CM MEDIUM ATTACHMENT

    MDR report key: 3984139 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-15922
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    August 16, 2006
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED BY DEPUY SYNTHES. ONCE THE DEVICE IS RECEIVED AND THE EVALUATION HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT "DURING THE END PROCEDURE OF THE DISC REMOVAL THE TIP OF THE MOUTHPIECE COVERS THE DISC AND THE POSTERIOR LONGITUDINAL LIGAMENT WHICH INCREASES THE DIFFICULTY TO USE THE INSTRUMENTATION". THE DEVICE WAS BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THE DATE OF EVENT IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663277 8.0 CM MEDIUM ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1