BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POST-OP KNEE ORTHOSIS

    MDR report key: 14470937 · Received May 20, 2022

    Report

    Report Number
    MW5109825
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    May 18, 2022
    Report Date
    May 18, 2022
    Manufacturer
    CORFLEX
    Product Code
    ITQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD QUAD TENDON REPAIR SURGERY ON (B)(6) 2022. I WAS GIVEN/SOLD A COREFLEX INC (B)(6) POST=OP KNEE ORTHOSIS (KNEE BRACE) LITE FOAM VERSION (BELIEVE MODEL 75-7500) ON (B)(6) 2022 BY MY ORTHOPEDIC SURGEON. THE BRACE CONTINUES TO SLIP DOWN MY LEG AND WON'T FASTEN CORRECTLY. THE ZIP TRACK BUTTONS ON THE TOP RIGHT SIDE DON'T HOLD THE STRAP IN PLACE AND CONTINUE TO SLIDE. I TOLD MY DOCTOR AND WAS GIVEN A REPLACEMENT ON (B)(6) 2022. MY IDENTICAL REPLACEMENT CONTINUES TO HAVE THE SAME EXACT PROBLEM. TODAY I CALLED COREFLEX AT (B)(4) AND SPOKE WITH (B)(4) IN CUSTOMER SERVICE. I DESCRIBED THE HISTORY ABOVE AND ASKED FOR A REPLACEMENT. SHE TOLD ME THAT I HAVE TO GO THROUGH MY DOCTOR. I TOLD HER THAT I WANTED TO LOG AN OFFICIAL FORMAL COMPLAINT WITH HER. THIS SEEMED FOREIGN TO HER AS SHE ONLY ASKED FOR MY EMAIL ADDRESS. I VOLUNTEERED MY NAME AND PHONE NUMBER AS WELL. (I HAVE WORKED IN THE MEDICAL DEVICE INDUSTRY FOR OVER 30 YEARS AND HAVE A QUALITY AND REGULATORY BACKGROUND.) I DID FOLLOW THE IFU AND ENSURED THAT MY LEG SIZE IS APPROPRIATE FOR THIS PARTICULAR DEVICE. SEVERAL PT THERAPISTS HAVE TOLD ME THAT THIS PARTICULAR LEG BRACE SLIPPING IS A COMMON PROBLEM. I REALIZE THAT INFO IS HEARSAY FOR THIS REPORT BUT THIS HAS BEEN THE WORST PART OF MY RECOVERY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342500 POST-OP KNEE ORTHOSIS JOINT, KNEE, EXTERNAL BRACE ITQ CORFLEX 75-7500

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male