BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVATOR X

    MDR report key: 11048020 · Received December 21, 2020

    Report

    Report Number
    3008523132-2020-00002
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    October 30, 2020
    Report Date
    January 14, 2021
    Manufacturer
    OSSUR MEXICO
    Product Code
    IOY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IFU PROVIDES INSTRUCTIONS THAT AFTER THE RANGE OF MOTION ADJUSTMENT IN STEP 8 FOR "ENFORCED COMPLIANCE: LOOP AND SECURE THE ENCLOSED LOCK TIES THROUGH THE HOLES IN THE FLEXION AND EXTENSION BUTTONS TO LIMIT RANGE OF MOTION ADJUSTMENT." NO FIELD ACTION, CORRECTION, OR REMOVAL IS REQUIRED AS THIS IS CONSIDERED USE ERROR, WHERE THE ZIP TIES WEREN'T INSTALLED AND THIS IS THE FIRST REPORTED OCCURRENCE OF SHARP EDGES. THE IFU PROVIDES CLEAR INSTRUCTION THAT ZIP TIES WERE TO BE INSTALLED AFTER THE RANGE OF MOTION WAS APPROPRIATELY ADJUSTED. TREND ANALYSIS: (B)(4). SALES: 141,885. ROM INADEQUATE: 1. SHARP EDGE: 1. P1 (ROM): 1/141885 = 7.05E-06. P1 (SHARP EDGE): 1/141885 = 7.05E-06.

    Description of Event or Problem · 0

    THE PATIENT HAD SURGERY ON A TORN BICEPS ON (B)(6) 2020. AFTER A FEW WEEKS CASTING THE BRACE WAS FITTED ON THE ARM. LATER THAT DAY THE PATIENT WAS STARTLED BY SOMETHING AND STRETCHED HIS RIGHT ELBOW, CAUSING THE LOCK TO LOOSEN DUE TO USE ERROR AS THE ZIP TIES WEREN'T INSTALLED TO PREVENT UNINTENDED INCREASE OF MOTION. THE PATIENT TORE HIS BICEPS AGAIN, AND IT IS NOT POSSIBLE TO UNDERGO A SECOND OPERATION. AS A RESULT, THE PATIENT HAS LIMITED STRENGTH IN HIS ARM. HE MAY REGAIN A CERTAIN DEGREE OF STRENGTH AND MOBILITY WITH ENOUGH PHYSICAL THERAPY. PATIENT INDICATED THAT BRACE IS VERY UNCOMFORTABLE DURING USE AND HE IS NOT HAPPY WITH THE BRACE IN GENERAL.

    Description of Event or Problem · 1

    THE PATIENT HAD SURGERY ON A TORN BICEPS IN (B)(6) 2020. AFTER A FEW WEEKS CASTING THE INNOVATOR X WAS FITTED ON THE ARM. LATER THAT DAY THE PATIENT WAS STARTLED BY SOMETHING AND STRETCHED HIS RIGHT ELBOW, CAUSING THE LOCK TO LOOSEN. PATIENT INDICATED THAT BRACE IS VERY UNCOMFORTABLE DURING USE AND HE IS NOT HAPPY WITH THE BRACE IN GENERAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517617 INNOVATOR X ELBOW BRACE IOY OSSUR MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability