BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 115

    MDR report key: 14262947 · Received May 2, 2022

    Report

    Report Number
    3013461531-2022-00015
    Event Type
    Injury
    Date Received
    May 2, 2022
    Report Date
    April 28, 2022
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    PMA / PMN Number
    H170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCTION PROCESS ANALYSIS: A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO SPECIFICATION. SURGEON INFORMATION ANALYSIS: NO INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT AS TO THE REASON FOR REVISION. EVALUATION OF THE PATIENT X-RAYS DEMONSTRATES THAT THE PATIENT PRE-OP KYPHOSIS ANGLE WAS OUT OF THE INDICATION (> 55°) AND THAT THE LOWER SCREW WAS PLACED OUT OF THE PEDICLE. THUS THE COMPANY ESTIMATES THAT THE REVISION IS DUE TO THE KYPHOSIS PROGRESSION AND LACK OF CORRECTION OF THE PRIMARY CURVE. RISK ASSESSMENT: REOPERATION EVENTS ARE A KNOWN RISK THAT WAS ASSESSED AND RECORDED BY THE PRODUCT RISK ASSESSMENT DMS-777 REV Q THIS COMPLAINT DOES NOT CHANGE THE OCCURRENCES RATE.

    Description of Event or Problem · 0

    PATIENT # (B)(6) WAS OPERATED ON (B)(6) 2020. THE SURGEON SECRETARY INFORMED APIFIX THAT REVISION SURGERY IS PLANNED FOR (B)(6) 2022, NO OTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073258 MID-C 115 POSTERIOR RATCHETING ROD SYSTEM QGP APIFIX LTD MID-C 115 AF 11-01-18

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention