BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 3181991 · Received June 17, 2013

    Report

    Report Number
    3004608878-2013-00115
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 17, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN A 1059 MAYFIELD SKULL CLAMP WAS INVOLVED IN A SLIPPAGE WHICH RESULTED IN A PATIENT INCURRING A LACERATION. THE FOLLOWING INFORMATION WAS PROVIDED. TYPE OF PROCEDURE BEING DONE AT THE TIME WAS A THORACIC 9 LAMINECTOMY. EN BLOC RESECTION OF THORACIC 10 POSTERIOR ELEMENTS, THORACIC 8-12 POSTERIOR INSTRUMENTATION USING MEDTRONIC SOLERA PEDICLE SCREWS. THE PATIENT HAD NOT BEEN REPOSITIONED PRIOR TO THE SLIPPAGE/LACERATION, BUT THE PATIENT INCURRED A LACERATION AS A RESULT OF THIS EVENT. STAPLES WERE REQUIRED TO REPAIR THIS INJURY. THE SURGERY WAS DELAYED 30-40 MINUTES IN ORDER TO STOP THE BLEEDING AND REPAIR THE LACERATION. THE PATIENT DID RECOVER FROM THE LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272927 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention