BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 10319496 · Received July 24, 2020

    Report

    Report Number
    3004608878-2020-00396
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    June 8, 2020
    Report Date
    June 29, 2020
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    PRE-AMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE UNIT WAS RECEIVED WITH THE LOCK HAVING ROTATIONAL AND LATERAL MOVEMENT; THE LOCK WAS HARD TO LOCK AND A RESIDUE BUILDUP WAS PRESENT. THE UNIT NEEDED NEW COMPONENTS ADDED TO REPLACE WORN INTERNAL PARTS. NO DEVICE HISTORY RECORD (DHR) REVIEW WAS POSSIBLE AS THE LOT NUMBER PROVIDED 021328 DOES NOT APPEAR TO BE A VALID INTEGRA NUMBER. NO OTHER LOT OR SERIAL NUMBER WAS PROVIDED DURING THE COMPLAINT INVESTIGATION. THE REPORTED COMPLAINT WAS CONFIRMED FROM THE EVALUATION. THE RETURNED UNIT DID NOT MEET ALL SPECIFIC FUNCTIONAL TEST. THE COMPLAINT WAS LIKELY CAUSED BY WEAR AND TEAR / IMPROPER HANDLING.THE DEFINITE ROOT CAUSE COULD NOT BE RELIABLY DETERMINED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A BIOMEDICAL TECHNICIAN REPORTED THAT THE A1059 MAYFIELD MODIFIED SKULL CLAMP TOOK TOO MUCH FORCE TO CLOSE AND AS A RESULT, THE FRAME CLOSES TOO MUCH AT ONCE AND NOT GRADUALLY. THE INCIDENT OCCURRED ON (B)(6) 2020. THERE WAS NO KNOWN PATIENT INJURY OR SURGERY DELAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787867 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1