BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE MCP SZ 20

    MDR report key: 9379394 · Received November 26, 2019

    Report

    Report Number
    1651501-2019-00049
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    October 14, 2019
    Report Date
    November 1, 2019
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KYJ
    PMA / PMN Number
    K022892
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H2, H3, H11. CORRECTED INFORMATION: B5, G4, G7, H6, H10. DHR - A REVIEW OF THE LOT RECORDS WAS CONDUCTED AND THERE WERE NO INDICATIONS OF PROBLEMS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT. THE IMPLANT WAS STERILIZED ACCORDING TO SPECIFICATIONS WITH NO ISSUES DOCUMENTED. FAILURE ANALYSIS - THE PART WAS NOT RETURNED TO INTEGRA FOR INVESTIGATION, SO THE FAILURE COULD NOT BE CONFIRMED. IF THE PART IS LATER RETURNED TO INTEGRA THIS INVESTIGATION MAY BE REOPENED AND UPDATED. ROOT CAUSE - A DEFINITIVE ROOT CAUSE FOR THE ALLEGED INFECTION COULD NOT BE DETERMINED DUE TO LIMITED INFORMATION REGARDING CLEANING AND USE OF THE IMPLANT AND DUE TO THE PART NOT BEING RETURNED. 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)(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 INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION 18 DAYS AFTER THE IMPLANTATION OF A SILICONE MCP. THE PATIENT IMPROVED WITH ORAL ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 1 OF 2 REPORTS: OTHER MFG REPORT NUMBER: 1651501-2019-00050.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171729 SILICONE MCP SZ 20 SILICONE MCP KYJ ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR