BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1071358 · Received July 7, 2008

    Report

    Report Number
    3004608878-2008-00043
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DEVICE SLIPPED CAUSING A PT INJURY. OBTAINED ADDITIONAL INFO FROM THE NEURO-COORDINATOR ON 06/26/2008. WAS ADVISED THAT THE MALE PT WAS UNDERGOING A POSTERIOR CERVICAL FUSION. THE "SLIPPAGE CONDITION" OCCURRED DURING THE SET-UP OF THE PROCEDURE AND RESULTED IN A SKULL LACERATION APPROXIMATELY 2 1/2 CM LONG. THE PT REQUIRED SEVERAL STAPLES. THERE WERE NO POST-OPERATIVE COMPLICATIONS TO HIS KNOWLEDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP NONE HBL INTEGRA LIFESCIENCES CORPORATION 350

    Patients

    Seq Age Sex Outcome Treatment
    1