BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 105L

    MDR report key: 11683216 · Received April 18, 2021

    Report

    Report Number
    3013461531-2021-00018
    Event Type
    Injury
    Date Received
    April 18, 2021
    Date of Event
    March 9, 2021
    Report Date
    April 12, 2021
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    PMA / PMN Number
    H170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    FIRST EVALUATION: PRODUCTION PROCESS: A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO APIFIX SPECIFICATIONS. PATIENT INFORMATION : BASED ON THE DISTRIBUTER INFORMATION THE REMOVAL SURGERY WAS PERFORMED DUE TO AN INFECTION. CORRECTIVE ACTION: FOLLOWING THE 2019 POST MARKET SURVELIANCE REPORT (DMS- (B)(4)), THE COMPANY DECIDED TO OPEN CAPA (B)(4) TO ADDRESS AN INCREASE IN LATE INFECTION COMPLAINTS. AS PART OF THE CAPA THE COMPANY: PERFORMED A VAST LITERATURE SEARCH TO IDENTIFY THE LATE INFECTION RATE REPORTED IN THE LITERATURE (DMS-(B)(4)). INVESTIGATED PRODUCTION LOTS ASSOCIATED WITH LATE INFECTION. THE COMPARED ANTIBIOTIC PROTOCOL USED BETWEEN CENTERS. RECEIVED CONSULTATION BY AN INFECTION SPECIALIST. THE CAPA INVESTIGATION DID NOT IDENTIFY A MANUFACTURING PROBLEM WITH IMPLANTS USED IN PATIENTS THAT DEVELOPED A LATE INFECTION AND THE LATE INFECTION RATE NOTED WAS WITHIN THE RATE REPORTED IN THE LITERATURE. THE COMPANY DID HOWEVER IDENTIFY THAT SITES APPLYING VANCOMYCIN POWDER BEFORE WOUND CLOSURE HAVE A SIGNIFICANTLY LOWER RATE OF LATE INFECTION COMPLAINTS. THE USE OF VANCOMYCIN POWDER WAS ALSO SUPPORTED BY THE INFECTION SPECIALIST CONSULTATION (DMS-(B)(4)) THE COMPANY COMMUNICATED THESE FINDINGS OF APPLYING VANCOMYCIN POWDER BEFORE WOUND CLOSURE TO THE SURGEONS (DMS-(B)(4)) AND IS CONTINUING TO FOLLOW THE RATE OF LATE INFECTION COMPLAINTS. RISK ASSESSMENT: LATE-ONSET INFECTION IS A KNOWN RISK THAT WAS ASSESSED AND RECORDED BY THE PRODUCT RISK ASSESSMENT DMS-(B)(4) REV Q HAZARD ID 21.5 THIS COMPLAINT DOES NOT CHANGE THE OCCURRENCES RATE. WE ASSUME THAT IN THE PRESENT CASE VANCOMYCIN WAS NOT APPLIED. THE TOTAL RATE OF LATE INFECTION IS 3.96% (N=20). OF THEM, ONLY 1 CASES WAS WHEN VANCOMYCIN WAS APPLIED WHICH IS 0.2% (1/505). THE RATE IS WELL WITHIN THE LITERATURE (0.2%-12.5% ,CER 727 REV T). THE COMPANY IS CONTINUING TO MONITOR LATE-INFECTION COMPLAINTS.

    Description of Event or Problem · 1

    THE PATIENT HAD A REMOVAL SURGERY ON (B)(6) 2021 DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580958 MID-C 105L POSTERIOR RATCHETING ROD SYSTEM,,, QGP APIFIX LTD MID-C 105 AF 11-04-17

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention