BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD COMPOSITE SERIES SKULL CLAMP

    MDR report key: 10277777 · Received July 15, 2020

    Report

    Report Number
    3004608878-2020-00089
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    January 16, 2020
    Report Date
    January 21, 2020
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    K142238
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - D10, G4, G7, H2, H3, H4, H6, H10 UDI # (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) SHOWED NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THE COMPLAINT WAS NOT CONFIRMED. INVESTIGATION SHOWED THAT THERE WAS MINIMAL MOVEMENT IN THE ROCKER ARM ASSEMBLY. HOWEVER, THE PRODUCT PASSED ALL FUNCTIONAL TESTING AND NO SLIPPAGE WAS NOTED. BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA PR 229048 AND NC 20-011 HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(4) OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    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. LINKED TO MFG REPORT NO.: 3004608878-2020-00090.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS. A SALES REPRESENTATIVE REPORTED IN BEHALF OF THE CUSTOMER THAT THE A3059 MAYFIELD COMPOSITE SERIES SKULL CLAMP SLIPPED AND CAUSED LACERATION. THE PATIENT WAS INITIALLY POSITIONED PRONE AND UPON SLIPPING, THE PRESSURE SETTINGS WERE NOTED TO BE AT 20 LBS RATHER THAN THE 60 LBS. THERE WAS A SURGICAL DELAY OF 45 MINUTES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020 INDICATING THAT THE UNIT WAS USED FOR A DECOMPRESSIVE CRANIECTOMY FOR CHIARI ON (B)(6) 2020. THE PATIENT WAS PLACED IN THE PRONE POSITION, SURGERY WAS NOT STARTED PRIOR TO LACERATION. THE PATIENT HAD AN APPROXIMATE 5CM SCALP LACERATION WHICH WAS CLOSED WITH SEVEN STAPLES. THE SKULL CLAMP WAS REPLACED TO COMPLETE THE PROCEDURE. THE PATIENT OUTCOME WAS REPORTED AS ¿UNKNOWN¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743652 MAYFIELD COMPOSITE SERIES SKULL CLAMP ¿COMPOSITE SERIES¿ HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1