BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD DISPOSABLE ADULT SKULL PINS (PLASTIC)

    MDR report key: 2783245 · Received October 3, 2012

    Report

    Report Number
    3004608878-2012-00177
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 11, 2012
    Report Date
    October 3, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A MAYFIELD MODIFIED SKULL CLAMP WAS REPORTEDLY IN CONTACT WITH A PATIENT THAT INCURRED A LACERATION. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012 WHICH WAS DESCRIBED AS FOLLOWS; THE SKULL PINS WERE IN CONTACT WITH PATIENTS SCALP, NOT THE ACTUAL MAYFIELD CLAMP DURING A CERVICAL DECOMPRESSION, LAMINECTOMY, FUSION C2-6 - POSTERIOR. THE PATIENT HAD BEEN INTUBATED AND THE MAYFIELD WAS SECURED TO THE HEAD WITH THE SKULL PINS FIRMLY IN PLACE. SHE WAS THEN POSITIONED PRONE ON THE OPERATING ROOM TABLE AND THE MAYFIELD SKULL CLAMP WAS THEN SECURED FIRMLY TO THE OPERATING ROOM TABLE. THE SURGERY WAS PERFORMED. THERE WAS NO REPOSITIONING OF THE PATIENT AT ANY TIME. THERE WAS NO SIGN OF INJURY DURING THE CASE (ID. BLOOD PRESENT ON FLOOR). AT THE END OF THE CASE, THE PATIENT WAS CAREFULLY TRANSFERRED FROM PRONE ON THE OPERATING ROOM TABLE TO THE SURGICAL BED. THE MAYFIELD CLAMP WAS THEN REMOVED FROM THE PATIENT. BLOOD WAS THEN NOTED ON THE PILLOW, AND THE LACERATION ON THE LEFT SIDE OF THE SCALP WAS FOUND. THE PHYSICIAN ASSISTANT HAD STATED HE HAD NOT FELT THE CLAMP SLIP WHEN PATIENT WAS TRANSFERRED, HE DID FEEL THAT HE DID NOT HAVE TO UNSCREW THE CLAMP AS FAR AS HE USUALLY DOES (ONLY 1 1/2 TURNS BEFORE IT WAS FREE FROM THE SCALP). THE MAYFIELD CLAMP AND PINS WERE USED FOR 4 HOURS AND 45 MINUTES. THERE WAS NO REVISION REQUIRED. THE LEFT SIDED SCALP LACERATION, REQUIRED WOUND CLOSURE WITH A SUTURE. THE SURGEON NOTED IN THE PROGRESS NOTE, PRIOR TO PATIENT DISCHARGE, THAT THE SCALP LACERATION WAS HEALING WELL. THE SKULL PINS USED WERE INTEGRA ADULT DISPOSABLE SKULL PINS (A1072) LOT# 1121846 EXPIRATION DATE 04/2014. THERE WAS NO STEREOTAXY DEVICE USED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD DISPOSABLE ADULT SKULL PINS (PLASTIC) NONE HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 1121846

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention