BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD DISPOSABLE ADULT SKULL PINS (PLASTIC)

    MDR report key: 4840273 · Received June 10, 2015

    Report

    Report Number
    3004608878-2015-00167
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 3, 2015
    Report Date
    May 18, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    K923789
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION 06/23/2015. RESULTS: PRODUCT NOT RELEASED FOR INSPECTION. THIS ITEM WAS MANUFACTURED ON MARCH 12, 2015 AND A REVIEW OF THE DHR CONTAINING LOT # 1150092 SHOWED THAT THIS LOT PASSED THE REQUIRED INSPECTION POINTS WITHOUT MRRS OR VARIANCES ONE REWORK WAS ISSUED FOR THIS LOT AT A LATER DATE TO RELABEL IN RESPONSE TO AN ORDER ERROR. THERE IS NO SERVICE HISTORY FOR THIS ITEM. NO MANUFACTURING OR DESIGN RELATED TREND HAS BEEN IDENTIFIED. CONCLUSION: 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

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A PT INCURRED A LACERATION TO HIS SCALP AFTER PLACEMENT OF THE MAYFIELD "TONGS." THE LACERATION REQUIRED STAPLING. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375151 MAYFIELD DISPOSABLE ADULT SKULL PINS (PLASTIC) ACCESSORIES HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 1150092

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention