BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSTERIOR RATCHETING ROD SYSTEM,

    MDR report key: 14336088 · Received May 9, 2022

    Report

    Report Number
    3013461531-2022-00017
    Event Type
    Injury
    Date Received
    May 9, 2022
    Date of Event
    April 7, 2022
    Report Date
    May 9, 2022
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    PMA / PMN Number
    H170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    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. EXPLANTED IMPLANT EVALUATION: THE PICTURE OF THE EXPLANTED IMPLANTS INDICATES ON IMPLANT BREAKAGE. RISK ASSESSMENT: (B)(4). THE RISK OF THE BROKEN ROD HAS BEEN ASSESSED AND FOUND TO BE ACCEPTABLE (DMS#777 REV Q1 HAZARD ID 1.8) THE RISK OF MID-C SYSTEM SURGICAL INSTRUMENTS (ACCESSORIES) DOES NOT FUNCTION PROPERLY HAS BEEN ASSESSED AND FOUND TO BE ACCEPTABLE (DMS#777 REV Q1 HAZARD ID 13.2) THIS COMPLAINT DOES NOT CHANGE THE PROBABILITY RATE.

    Description of Event or Problem · 0

    THE BELOW INFORMATION WAS RECEIVED BY THE COMPANY: ON (B)(6) 2021 A REVISION SURGERY TO MOVE THE CONTROL PIN TO NEUTRAL POSITION. ON (B)(6) 2022 AN ELECTIVE SURGERY WAS DONE TO REMOVE THE IMPLANT. DURING THE SECOND REVISION SURGERY WHEN REMOVED THE IMPLANT THE POLE COMPONENT WAS SEPARATE FROM THE BASE , THE DEMONSTRATE THE RETRIEVAL IMPLANT DEMONSTRATE ON POLE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552676 POSTERIOR RATCHETING ROD SYSTEM, MID-C 125 QGP APIFIX LTD MID-C 125 AF 03-01-19

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention