BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION OTPS BIOABSOBABLE FREEDOMPLATE

    MDR report key: 4780384 · Received May 14, 2015

    Report

    Report Number
    9710629-2015-00002
    Event Type
    Injury
    Date Received
    May 14, 2015
    Date of Event
    February 23, 2015
    Report Date
    April 21, 2015
    Manufacturer
    INION OY
    Product Code
    HRS
    PMA / PMN Number
    K063410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INION FREEDOMSCREWS WERE USED FOR THE FIXATION OF INION FREEDOMPLATE: (B)(4) - LOT 1208033. INION FREEDOMSCREW COMMON DEVICE NAME: BONE SCREW. INION FREEDOMSCREW PROCODE: HWC. INION FREEDOMSCREW 510(K) NUMBER: K123672. THE DOCTOR SUSPECTED IMMEDIATELY THAT THIS METAL ALLERGY PT HAD NOT BEEN COMPLIANT WITH INSTRUCTIONS.

    Description of Event or Problem · 1

    DR (B)(6) IN (B)(6) HAD TO REVISE THE CLAVICLE FREEDOM PLATE CASE INITIALLY DONE IN (B)(6). DR (B)(6) SUSPECTED IMMEDIATELY THAT THIS METAL ALLERGY PT HAD NOT BEEN COMPLIANT WITH INSTRUCTIONS. SHE DID NOT HAVE PROBLEMS REMOVING THE PLATE AND FOUND THAT IT HAD BROKEN IN TWO PLACES. SHE DECIDED TO FIX WITH A METAL PLATE. FRACTURE WAS REDUCED INTRA-OPERATIVE, SLIGHT GAP WAS NOTICED UNDER FLOUROSCOPIA. PT WAS TOLD TO BE NON-WEIGHT BEARING FOR 6 WEEKS. PT HEARD A POPPING SOUND THAT SAME DAY AS INITIAL OPERATION, REMOVED (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316961 INION OTPS BIOABSOBABLE FREEDOMPLATE BONE PLATE HRS INION OY UNK 1303005

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention