BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION OTPS BIOABSORBABLE FREEDOMPLATE

    MDR report key: 4823587 · Received June 5, 2015

    Report

    Report Number
    9710629-2015-00004
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    March 3, 2015
    Report Date
    May 11, 2015
    Manufacturer
    INION OY
    Product Code
    HRS
    PMA / PMN Number
    K063410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INION FREEDOMSCREWS WERE USED FOR THE FIXATION OF INION FREEDOMPLATE: OSA-3545, LOT 1410022. INION FREEDOMSCREW COMMON DEVICE NAME: BONE SCREW; INION FREEDOMSCREW PROCODE: HWC; INION FREEDOMSCREW 510(K) NUMBER: K123672. THE PLATE HAS BEEN EXPOSED TO ONE-TIME HIGH FORCE EXCEEDING THE MECHANICAL STRENGTH OF THE PLATE (RATHER THAN TO CYCLIC/FATIGUE TYPE OF LOADING). POSSIBLE REASONS FOR THIS TYPE OF ONE-TIME OVERLOADING CAN ONLY BE SPECULATED BUT COULD BE E.G., PT BEARING TOO MUCH LOAD ON THE ARM TOO EARLY, PT FALLING OR LEANING ON THE ARM TOO EARLY, PT STARTING TOO AGGRESSIVE A REHABILITATION TOO EARLY, PT ROTATING THE ARM TOO EARLY, PT ACCIDENTALLY PICKING UP/LIFTING SOMETHING TOO EARLY. IN CONCLUSION, WITH THIS PT POSTOPERATIVE IMMOBILIZATION WITH PLASTER CAST PERHAPS SHOULD HAVE BEEN CONTINUED LONGER THAN FOR 2 WEEKS.

    Description of Event or Problem · 1

    RADIUS FRACTURE OF A (B)(6) FEMALE WAS OPERATED ON (B)(6) 2015 USING INION FREEDOMPLATE AND INION FREEDOMSCREWS. PT HAD A PLASTER CAST IMMOBILIZATION FOR TWO WEEKS. BASED ON THE X-RAYS TAKEN TWO WEEKS POSTOPERATIVELY, THE FRACTURE ALIGNMENT AND REDUCTION WAS GOOD BUT THE FRACTURE LINES COULD BE STILL SEEN CLEARLY AND THERE WAS NO SIGN OF BONE HEALING YET. HOWEVER, AT THIS POINT THE PLASTER CAST WAS REMOVED AND REPLACED WITH A FOREARM ORTHOSIS, AND TWO WEEKS LATER THE PT WAS INSTRUCTED TO START MOVING THE FINGERS AND THE WRIST DUE TO THE GROWING ABDUCTOR CONTRACTURE OF THE THUMB AND IN ORDER TO AVOID ADJACENT JOINTS AND TENDONS GETTING STIFF. RE-FRACTURE AND ANGULATION OF RADIUS WAS NOTICED ON (B)(6) 2015. INION FREEDOMPLATE AND FREEDOMSCREWS WERE REMOVED IN RE-OPERATION ON (B)(6) 2015. THE PLATE WAS FRACTURED INTO TWO PIECES. OTHER PLATE FRACTURES OCCURRED DURING THE REMOVAL OF THE PLATE WHEN THEY USED FORCE TO GET THE PLATE PIECES DETACHED FROM THE BONE. THE FRACTURE WAS RE-OPERATED WITH A METAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366186 INION OTPS BIOABSORBABLE FREEDOMPLATE BONE PLATE HRS INION OY 1401018

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention