BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 105

    MDR report key: 12983521 · Received December 13, 2021

    Report

    Report Number
    3013461531-2021-00045
    Event Type
    Injury
    Date Received
    December 13, 2021
    Date of Event
    November 11, 2021
    Report Date
    December 7, 2021
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    PMA / PMN Number
    H170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: PRODUCTION PROCESS: A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO APIFIX SPECIFICATIONS. SURGEON INFORMATION AND X-RAY ANALYSIS: AFTER REVISION SURGERY ( MDR# 3013461531-2021-00014) THE PATIENT DISPLAYED SIGNIFICANT TORSO IMBALANCE. THE PATIENT WAS REFERRED TO SCHROTH EXERCISES IN AN ATTEMPT TO RESOLVE THE IMBALANCE . RISK ASSESSMENT: THE RISK OF SPINE IMBALANCE IS A KNOWN RISK. THE CURRENT SPINE IMBALANCE COMPLAINT RATE IS (B)(4) AND HAS BEEN ASSESSED AND FOUND TO BE ACCEPTABLE PER THE COMPANY CER. (DMS-727 REV T) THE EVENT OF SPINE IMBALANCE IS ADDRESSED IN THE IFU AS POTENTIAL RISKS ASSOCIATED WITH THE MID-C SYSTEM 1. CURVE PROGRESSION ABOVE OR BELOW THE IMPLANT 2. LORDOSIS/KYPHOSIS CHANGES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: PRODUCTION PROCESS: A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO APIFIX SPECIFICATIONS. SURGEON INFORMATION AND X-RAY ANALYSIS: AFTER REVISION SURGERY ( MDR# 3013461531-2021-00014) THE PATIENT DISPLAYED SIGNIFICANT TORSO IMBALANCE. THE PATIENT WAS REFERRED TO SCHROTH EXERCISES IN AN ATTEMPT TO RESOLVE THE IMBALANCE . RISK ASSESSMENT: THE RISK OF SPINE IMBALANCE IS A KNOWN RISK. THE CURRENT SPINE IMBALANCE COMPLAINT RATE IS 0.51% AND HAS BEEN ASSESSED AND FOUND TO BE ACCEPTABLE PER THE COMPANY CER. (DMS-727 REV T) THE EVENT OF SPINE IMBALANCE IS ADDRESSED IN THE IFU AS POTENTIAL RISKS ASSOCIATED WITH THE MID-C SYSTEM 1. CURVE PROGRESSION ABOVE OR BELOW THE IMPLANT 2. LORDOSIS/KYPHOSIS CHANGES.

    Description of Event or Problem · 0

    THE PATIENT CONTACTED THE SURGEON FOR A VIRTUAL CONSULT ON ADDITIONAL TREATMENT OPTIONS TO REPLACE THE APIFIX SYSTEM.

    Description of Event or Problem · 0

    THE PATIENT CONTACTED THE SURGEON FOR A VIRTUAL CONSULT ON ADDITIONAL TREATMENT OPTIONS TO REPLACE THE APIFIX SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1888243 MID-C 105 POSTERIOR RATCHETING ROD SYSTEM, QGP APIFIX LTD MID-C 105 AF 11-05-17

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention