BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIMEND PRS MESHED 20CM X 10CM X 1MM INTL

    MDR report key: 10283131 · Received July 16, 2020

    Report

    Report Number
    3004170064-2020-00002
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    November 26, 2019
    Report Date
    February 7, 2020
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    OXH
    PMA / PMN Number
    K171357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR FAILURE ANALYSIS. ROOT CAUSE IS UNDETERMINED. BASED ON THE DHR REVIEW CONDUCTED, THERE IS NO INDICATION THAT THE MANUFACTURING, QUALITY INSPECTIONS OR FINAL PACKAGING/LABELING PROCESSES MAY HAVE CONTRIBUTED TO THIS COMPLAINT. THERE WERE NO ANOMALIES FOUND IN THE DHR REVIEW. BETWEEN (B)(6)2019 AND (B)(6)2020, 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 (B)(4). 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 (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 (B)(6)2019 THROUGH (B)(6)2020. INTEGRA LIFESCIENCES CONTACTED (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGIMEND TORE DURING SURGERY: THE SURGEON HYDRATED THE MESH AS NORMAL IN SALINE. SUTURED THE MESH TO THE INFERIOR AND MEDIAL ASPECTS OF THE CHEST WALL POCKET ON A NIPPLE SPARING MASTECTOMY AND RECONSTRUCTION CASE. THE SURGEON THEN INSERTED A 335CC IMPLANT AND ON STRETCHING THE SURGIMEND TO COVER THE IMPLANT IT TORE WITHIN HER HANDS. NO EXCESSIVE FORCE WAS USED (OR REQUIRED). THE SURGEON HAS USED SM PP MORE THAN 25 TIMES PREVIOUSLY, SHE IS GENERALLY A VERY CAREFUL SURGEON. THEN THE SURGEON USED A PIECE OF 8X16CM PRS SM TO COVER THE LOWER AND LATERAL ASPECTS OF THE IMPLANT, WHICH WOULD BE IN CONTACT WITH THE SM MESHED IN QUESTION. NO PATIENT INJURY WAS REPORTED AND THE EVENT LED TO 60 MINUTES SURGICAL DELAY. NOTE: THIS IS AN EVENT THAT WAS REPORTED FROM THE (B)(4) WHICH INCLUDES INDICATIONS FOR BREAST RECONSTRUCTION. HOWEVER, THE PRODUCT IN THE US DOES NOT HAVE THIS INDICATION. THE REPORTED CATALOG IS NOT FOR SALE IN THE US MARKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751163 SURGIMEND PRS MESHED 20CM X 10CM X 1MM INTL SURGIMEND OXH TEI BIOSCIENCES INC 1905051

    Patients

    Seq Age Sex Outcome Treatment
    1