BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD 2000 SKULL CLAMP

    MDR report key: 5523934 · Received March 24, 2016

    Report

    Report Number
    3004608878-2016-00056
    Event Type
    Injury
    Date Received
    March 24, 2016
    Date of Event
    March 2, 2016
    Report Date
    March 3, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    K932807
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 20 MAY 2016. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS HAS NOT BEEN PERFORMED. THE DEVICE IN QUESTION WAS NOT SENT IN FOR INSPECTION NOR WAS THE LOT NUMBER PROVIDED. THE LOT NUMBER COULD BE 127. THIS DEVICE WAS MANUFACTURED ON 07/31/2012 AND A REVIEW OF THE DHR CONTAINING LOT CODE 127 SHOWED THAT THIS DEVICE PASSED THE REQUIRED INSPECTION POINTS WITHOUT REWORKS, MRRS OR VARIANCES: THERE IS NO SERVICE HISTORY FOR THIS DEVICE. CONCLUSION: IN SUMMARY THE END USERS EXPERIENCE COULD NOT BE VERIFIED AS PRODUCT WAS NOT SENT IN FOR INSPECTION ALTHOUGH SEVERAL ATTEMPTS WERE MADE. THIS CUSTOMER¿S INQUIRY WITH RESPECT TO THE DESIGN OF THE DEVICE IN QUESTION WAS SUBMITTED TO PRODUCT DEVELOPMENT FOR REVIEW HOWEVER NO ROOT CAUSE FOR THE REPORTED FAILURE COULD BE DETERMINED FROM THE LIMITED DETAILS PROVIDED. AN ASSESSMENT OF THIS CUSTOMERS SERVICE HISTORY WAS PERFORMED BUT NO RECORDS WERE ON FILE FOR THIS PRODUCT ID. THIS COMPLAINT WILL BE REOPENED SHOULD WE RECEIVE PRODUCT.

    Description of Event or Problem · 1

    AN INTEGRA SALES REP RECEIVED AN EMAIL STATING THAT A DOCTOR WAS REPORTING A SLIP THAT HAD OCCURRED WHILE USING THE A2000 MAYFIELD SKULL CLAMP WHICH CAUSED A LACERATION. THE INCIDENT OCCURRED ON (B)(6) 2016; THE PATIENT, WHOSE AGE AND GENDER WERE UNKNOWN, WAS UNDERGOING A CERVICAL PROCEDURE. THE LACERATION WAS 1.5CM ON THE LEFT PARIETAL SCALP AND IT REQUIRED PRIMARY CLOSURE AS THE MEDICAL INTERVENTION. INTEGRA DISPOSABLE SKULL PINS WERE USED. THERE WAS A 1 HOUR DELAY IN SURGERY TIME DUE TO THE EVENT. THERE WAS NO OTHER APPARENT SEQUELAE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180888 MAYFIELD 2000 SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R