BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIEL MODIFIED SKULL CLAMP

    MDR report key: 4864904 · Received June 22, 2015

    Report

    Report Number
    3004608878-2015-00177
    Event Type
    Injury
    Date Received
    June 22, 2015
    Report Date
    May 29, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION 07/10/2015. RESULTS: A DHR REVIEW CANNOT BE PERFORMED AT THIS TIME AS THE LOT NUMBER WAS NOT PROVIDED OR WAS THE PRODUCT SENT IN FOR INSPECTION FOR THE DEVICE INVOLVED COULD NOT BE LOCATED BY THE END USER. NO MANUFACTURING OR DESIGN RELATED TREND HAS BEEN IDENTIFIED. CONCLUSION: IN SUMMARY - THE DEVICE WAS NOT RELEASED FOR EVALUATION THEREFORE THE ROOT CAUSE TO THE END USERS EXPERIENCE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE REOPENED SHOULD WE RECEIVE PRODUCT.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A POSSIBLE SLIP WAS REPORTED. THE PATIENT HAD A "SCRATCH" AFTER THE CASE. DATE OF THE INCIDENT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 11JUN2015: THE INCIDENT HAD HAPPENED LONG AGO AND THE NEURO COORDINATOR ONLY CAME TO KNOW ABOUT THE INCIDENT WEEKS AFTER. SHE STATED THE PATIENT JUST HAD A SCRATCH, NOT A SERIOUS INJURY. SHE MENTIONED THAT THE PHYSICIAN WAS TRAINING HIS PA (PHYSICIAN ASSISTANT) WHEN THE INCIDENT OCCURRED. SHE HAD NO OTHER INFORMATION TO PROVIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403797 MAYFIEL MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other