BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD TRIAD

    MDR report key: 2987697 · Received December 27, 2004

    Report

    Report Number
    1525725-2004-00025
    Event Type
    Other
    Date Received
    December 27, 2004
    Date of Event
    November 30, 2004
    Report Date
    November 30, 2004
    Manufacturer
    SCHAERER MAYFIELD USA, INC.
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED TO INTEGRA LIFESCIENCES CORPORATION FOR EVAL AND POSSIBLE REPAIR. THE FOLLOWING INFO IS A SUMMARY OF THE EVAL AND CONCLUSION RESULTS. EVAL: THE UNIT HAD A REPAIR HISTORY IN THE INTEGRA LIFESCIENCES CORP. REPAIR DEPT. FILES. THE BASE CASTING AND EXTENSION ARM HAD DIFFERENT PREVIOUS REPAIR CODES ON THEM, INDICATING THE HOSPITAL HAS MIXED MATCHED PARTS FROM DIFFERENT SKULL CLAMPS. THE PARTS ARE NOT ALWAYS INTERCHANGEABLE, BUT IT DID NOT CAUSE A PROBLEM IN THIS SKULL CLAMP. THE SWIVEL LOCK HAD A POSITION LOCK WITH LITTLE OR NO MOVEMENT IN THE LOCKED POSITION. THE SKULL CLAMP WAS POSITIONED, ADJUSTED AND LOCKED PROPERLY, THEN IT WAS TESTED UNDER PRESSURE AND THE REPORTED PROBLEM "CAME UNLOCKED" COULD NOT BE DUPLICATED. THE SKULL CLAMP DID NOT REQUIRE REPAIRS. CONCLUSION: BASED ON THE NATURE OF THE PROBLEM AND EVAL RESULTS OF INTEGRA LIFESCIENCES CORP., NO DIRECT CONCLUSION COULD BE DETERMINED AS TO HOW OR WHY THE DEVICE ALLEGEDLY "CAME UNLOCKED", RESULTING IN A PT LACERATION. CORRECTIVE ACTION: NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. HOWEVER, AS AN AID TO THE NEUROSURGERY STAFF, INTEGRA LIFESCIENCES CORPORATION WILL SEND A COPY OF THE CD "MAYFIELD PROPER SKULL CLAMP POSITIONING". THE STAFF SHOULD FIND THIS HELPFUL.

    Description of Event or Problem · 1

    UNIT CAME UNLOCKED, LACERATION, INCIDENT. REPORTER WITNESSED EVENT, PT WAS HARMED, FEMALE, (B)(6), EQUIPMENT MALFUNCTION. THE SKULL CLAMP WAS PLACED ON PT BY RESIDENT. THE INCIDENT OCCURRED DURING INITIAL POSITIONING FOR A CHIARI PROCEDURE, WHILE PT WAS PRONE. THE INJURY WAS TO THE LEFT PARA/TEMP, APPROX 2-3 CM AND REQUIRED CONTROL MEASURES (6 STITCHES). THERE ARE NO POST-OPERATIVE COMPLICATIONS TO THE PT FROM THE EVENT. THE SKULL CLAMP WAS PLACED TO PUT INTO LOCKED POSITION. IT DID NOT LOCK PROPERLY, PIN ASSEMBLY ROTATED AND PT SLIPPED OUT OF PINS RESULTING IN LACERATION. THE FACILITY REPORTED THAT THEY HAD CONTINUAL PROBLEMS WITH THE LOCKING MECHANISM FOR THESE CLAMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD TRIAD SKULL CLAMP HBL SCHAERER MAYFIELD USA, INC. 40A1108 037

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other