BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 6508451 · Received April 20, 2017

    Report

    Report Number
    3004608878-2017-00124
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    November 26, 2016
    Report Date
    April 4, 2017
    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 · 1

    INVESTIGATION COMPLETED 4/27/17. WORK ORDER# 133619/ LOT# 159/ SERIAL# (B)(4): THE DEVICE HISTORY RECORD FOR THIS UNIT SHOWS THAT THIS PART WAS MANUFACTURED ON 10/16/2015. A TOTAL OF (B)(4) WERE PRODUCED OF THIS WORK ORDER NUMBER AND LOT NUMBER. NO ABNORMALITIES RELATED TO REPORTED INCIDENT FOUND NOR WERE THERE ANY VARIANCES, MRR¿S OR REWORKS ASSOCIATED WITH THIS WORK ORDER NUMBER AND LOT NUMBER. NO SERVICE HISTORY IS ON FILE FOR THIS DEVICE. CONCLUSION: IN SUMMARY, THE DEVICE IN QUESTION WAS NOT RECEIVED FOR EVALUATION AFTER SEVERAL DOCUMENTED ATTEMPTS. THEREFORE, THE ROOT CAUSE TO THE END USERS EXPERIENCE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE REOPENED SHOULD WE RECEIVE PRODUCT.

    Description of Event or Problem · 1

    THE HOSPITAL SENT BACK THE A1059 TO THE DISTRIBUTOR TO FIX THE DEVICE BECAUSE THE HELICOIL WAS PROTRUDING OUTWARDS. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288826 MAYFIELD MODIFIED SKULL CLAMP N/A HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 133619/159

    Patients

    Seq Age Sex Outcome Treatment
    1