BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIOLUCENT 2000 BASE SYSTEM

    MDR report key: 10279341 · Received July 15, 2020

    Report

    Report Number
    3004608878-2020-00145
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    January 22, 2020
    Report Date
    February 28, 2020
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    PMA / PMN Number
    PRE-AMEND
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10, G4, G7, H2, H3, H6, H10. UDI # (B)(4). THE PRODUCT WAS NOT RETURNED FOR EVALUATION. NO DEVICE HISTORY RECORD (DHR) REVIEW WAS POSSIBLE SINCE THE LOT NUMBER 437C1073 DOES NOT APPEAR TO BE A VALID INTEGRA NUMBER. THE REPORTED COMPLAINT WAS NOT CONFIRMED. 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 RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG REPORT NUMBER 3004608878-2020-00150.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS. A MEDWATCH FORM WITH UF/ IMPORTER REPORT # 2000330000-2020-8006 WAS RECEIVED ON (B)(6) 2020 WITH THE FOLLOWING INFORMATION: A (B)(6) YEAR-OLD FEMALE PATIENT SUSTAINED A 3-INCH LACERATION DURING A NEUROSURGICAL PROCEDURE ON THE FRONT UPPER LEFT SIDE OF THE HEAD FROM ONE OF THE MAYFIELD PINS. THIS OCCURRED WHILE REPOSITIONING THE PATIENT FROM SUPINE TO PRONE USING THE RADIOLUCENT MAYFIELD HEADREST. ON (B)(6) 2020, A FUNCTIONALITY TEST WAS DONE WHERE THE PINS AND SKULL CLAMP WERE FUNCTIONING AS INTENDED. THERE WAS NO SLIPPAGE NOTED ON THE PHANTOM HEAD WHEN THE CLAMP WAS POSITIONED. ADDITIONAL INFORMATION RECEIVED ON 05MAR2020 STATED THAT THE PATIENT HAD UNDERGONE A C5-6 ANTERIOR CERVICAL FUSION AND C3-7 POSTERIOR CERVICAL FUSION. THE MAYFIELD DEVICE WAS REPOSITIONED AND CLAMPED BACK ON PATIENT. PROCEDURE WAS COMPLETED AND DEVICE SEQUESTERED AFTER FOR A FUNCTIONAL TEST. THE 3- INCH LACERATION WAS CLEANED, STITCHED AND STAPLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740592 RADIOLUCENT 2000 BASE SYSTEM SKULL CLAMPS AND HEADREST SYSTEMS FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA 437C1073

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR A1083 MAYFIELD ADULT PINS LOT #: W1904076