BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD SWIVEL ADAPTOR

    MDR report key: 10276868 · Received July 15, 2020

    Report

    Report Number
    3004608878-2019-01130
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    December 2, 2019
    Report Date
    December 3, 2019
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION THE DHR WAS NOT COMPLETED DUE TO THE SERIAL NUMBER PROVIDED DOES NOT APPEAR TO BE A VALID INTEGRA NUMBER. FAILURE ANALYSIS COMPLETED AND THE INVESTIGATION WAS UNABLE TO CONFIRM THE COMPLAINT, AS THE DEVICE PASSED ALL FUNCTIONAL TESTS "1101 FUNCTION TEST". 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 (B)(4) 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)(6) , DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(6) , ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT 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 # 3004608878-2019-01129.

    Description of Event or Problem · 1

    1 OF 2 REPORTS. A CUSTOMER REPORTED THAT ON (B)(6) 2019, THE SKULL OF THE PATIENT WAS FIXED IN THE SKULL CLAMP A-1114, ((B)(4)) AND IN THE MAYFIELD SYSTEM AS USUAL. AFTER A SHORT TIME, THERE WAS LOOSENING ON THE CONNECTION OF THE A1018 ((B)(4)) TO THE A1114 AND THE PATIENTS HEAD CHANGED ITS POSITION. BECAUSE OF THIS MOVEMENT THE PATIENT SUFFERED A SKIN INJURY THROUGH THE SKULL-PIN. THE DURATION OF THE SURGERY WAS EXTENDED (UNSPECIFIED TIME) AS THE MAYFIELD SYSTEM NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743235 MAYFIELD SWIVEL ADAPTOR SKULL PINS FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA 9141

    Patients

    Seq Age Sex Outcome Treatment
    1