BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD TRIAD SKULL CLAMP

    MDR report key: 4833924 · Received June 8, 2015

    Report

    Report Number
    3004608878-2015-00165
    Event Type
    Injury
    Date Received
    June 8, 2015
    Date of Event
    November 28, 2014
    Report Date
    May 14, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION 06/23/2015. RESULTS: THE DEVICE IN QUESTION WAS NOT RELEASED FOR INSPECTION AS THE CUSTOMER HAS PERMANENTLY REMOVED IT OUT OF SERVICE THE MOST LIKELY LOT CODES COULD BE (B)(4) MANUFACTURED IN DECEMBER 31, 1987) AND OR (B)(4) (MANUFACTURED IN 1987) FOR THE DEVICE IN QUESTION. NO MANUFACTURING OR DESIGN RELATED TREND HAS BEEN IDENTIFIED. CONCLUSION: IN SUMMARY, THE DEVICE IN QUESTION WAS INSPECTED BY A SALES REPRESENTATIVE AND FOUND THAT THE SWIVEL LOCK WAS TOO LOOSE AND THERE WAS ROCKER ARM MOVEMENT WHEN LOCKED. THIS DEVICE HAS BEEN PERMANENTLY REMOVED FROM SERVICE.

    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

    A REPORT WAS RECEIVED REGARDING A MAYFIELD TRIAD SKULL CLAMP VIA MAUDE REPORT NUMBER (B)(4). THE DESCRIPTION IS AS FOLLOWS; "MAYFIELD HEAD HOLDER PLACED ON THE PATIENT. THE HEAD HOLDER SLIPPED, CAUSING A LACERATION TO THE SCALP. SCALP WAS STAPLED. MAYFIELD EQUIPMENT INSPECTED BY SERVICE REPRESENTATIVE AND FOUND THAT THE SWIVEL LOCK WAS TOO LOOSE AND THERE WAS ROCKER ARM MOVEMENT WHEN LOCKED." FURTHER INFORMATION RECEIVED WAS AS FOLLOWS; TYPE OF PROCEDURE BEING DONE AT THE TIME: EMERGENT REDO CERVICAL AND THORACIC SPINAL DISSECTION, C3 T3 FUSION. WAS THE PATIENT REPOSITIONED PRIOR TO THE SLIPPAGE/LACERATION? HEAD PLACED IN MAYFIELD HEAD HOLDER, ROLLED PRONE, CHEST SUPPORTED WITH LONGITUDINAL CHEST ROLLS. WAS THE SURGERY DELAYED AS A RESULT OF THIS EVENT? DELAYED MINIMALLY TO REPAIR LACERATION WITH STAPLES AND REAPPLY THE MAYFIELD HEAD HOLDER. DID THE PATIENT RECOVER FROM THE LACERATION? YES. TYPE OF SKULL PINS BEING USED? ADULT, DISPOSABLE, MANUFACTURER, LOT NUMBER: INTEGRA MAYFIELD SKULL PINS, DISPOSABLE A1083, NO LOT NUMBER AVAILABLE. WAS STEREOTAXY DEVICE ALSO USED DURING THE PROCEDURE? NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369310 MAYFIELD TRIAD SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other