BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 105

    MDR report key: 14191179 · Received April 24, 2022

    Report

    Report Number
    3013461531-2022-00014
    Event Type
    Injury
    Date Received
    April 24, 2022
    Date of Event
    March 16, 2022
    Report Date
    April 24, 2022
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    PMA / PMN Number
    H170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: PRODUCTION PROCESS ANALYSIS: A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO SPECIFICATION. PATIENT/ SURGEON INFORMATION: THE COMPANY DOES NOT KNOW FOR CERTAIN IF VANCOMYCIN POWDER WAS APPLIED IN THIS PROCEDURE BUT ESTIMATES WITH HIGH CERTAINTY BASED ON THE SURGEON'S PREVIOUS PRACTICE THAT VANCOMYCIN WAS NOT APPLIED IN THE PRESENT CASE. RISK ASSESSMENT: THE RISK OF INFECTION LATE IS A KNOWN RISK. THE CURRENT RATE OF THIS EVENT IS (B)(4) AND IS IN LINE WITH THE RATE REPORTED IN THE LITERATURE FOR THIS TYPE OF COMPLICATION AS DESCRIBED IN THE COMPANY'S CLINICAL EVALUATION REPORT (0.2%-12.5%) (CER (B)(4) REV U). THE EVENT OF WOUND COMPLICATION IS ADDRESSED IN THE IFU ((B)(4)) AS POTENTIAL RISKS ASSOCIATED WITH THE MID-C SYSTEM. CORRECTIVE ACTION: FOLLOWING THE 2019 PMS REPORT ((B)(4)), THE COMPANY DECIDED TO OPEN (B)(4)-19 TO ADDRESS AN INCREASE IN LATE INFECTION COMPLAINTS. AS PART OF THE CAPA THE COMPANY TOOK THE FOLLOWING ACTIONS: PERFORMED A VAST LITERATURE SEARCH TO IDENTIFY THE LATE INFECTION RATE REPORTED IN THE LITERATURE ((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 ((B)(4)). THE COMPANY COMMUNICATED THESE FINDINGS OF APPLYING VANCOMYCIN POWDER BEFORE WOUND CLOSURE TO THE SURGEONS ((B)(4)) AND IS CONTINUING TO FOLLOW THE RATE OF LATE INFECTION COMPLAINTS. PATIENT OUTCOME: REMOVAL. THE DEVICE WAS IN PLACE FOR FOUR YEARS. THE DEVICE WAS REMOVED WITH NO COMPLICATIONS OR CHALLENGES, AS MENTIONED IN THE REPORT.

    Description of Event or Problem · 0

    A NEW COMPLAINT WAS DUE TO LATE WOUND INFECTION. THE PATIENT WAS OPERATED FIRST ON (B)(6) 2018, IN (B)(6). REOPERATION (REMOVAL) WAS PERFORMED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045977 MID-C 105 POSTERIOR RATCHETING ROD SYSTEM, QGP APIFIX LTD MID-C 105 AF 11-01-17

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention