BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION OTPS BIOABSORBABLE FREEDOMPLATE

    MDR report key: 4619343 · Received March 19, 2015

    Report

    Report Number
    9710629-2015-00001
    Event Type
    Injury
    Date Received
    March 19, 2015
    Report Date
    February 18, 2015
    Manufacturer
    INION OY
    Product Code
    HRS
    PMA / PMN Number
    K063410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INION FREEDOMSCREWS WERE USED FOR THE FIXATION OF INION FREEDOMPLATE. INION FREEDOMSCREW COMMON DEVICE NAME: BONE SCREW. INION FREEDOMSCREW PROCODE: HWC. INION FREEDOMSCREW 510 (K) NUMBER: K123672. THE PT WAS EXTENDING HIS FINGERS ON THE 10TH DAY POST-OP ALTHOUGH ONLY LIMITED RANGE OF MOTION IS ALLOWED.

    Description of Event or Problem · 1

    DR. (B)(6) (USA) PERFORMED OSTEOTOMY WITH PLATE FIXATION USING INION FREEDOM PLATES AND INION FREEDOMSCREWS ON A PT WITH A 70 DEGREE SHAFT DEFORMITY OF THE 5TH METACARPAL AND A 40 DEGREE SHAFT DEFORMITY OF THE 4TH METACARPAL. THE PT REPORTED A POPPING SENSATION IN THE 5TH METACARPAL WHEN HE WAS FLEXING AND EXTENDING HIS FINGERS ON THE 10TH DAY AFTER SURGERY. RADIOGRAPHS DEMONSTRATED FAILURE OF FIXATION. THE PT WAS TAKEN TO THE OPERATIVE SUITE WHERE UNDERWENT REVISION OF FIXATION OF THE 5TH METACARPAL WITH INTRAMEDULLARY PINNING. THE PLATE WAS OBSERVED TO HAVE FAILED ALONG A SCREW HOLE IN THE PLATE ADJACENT TO THE OSTEOTOMY SITE OF THE 5TH METACARPAL WHILE THE 4TH METACARPAL FIXATION REMAINED INTACT. THE PT WENT ONTO UNEVENTFUL HEALING. LOSS OF FIXATION FROM EXCESSIVE ANGULATION CORRECTION. REVISION FIXATION PERFORMED WITH INTRAMEDULLARY FIXATION AND REMOVAL OF HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188626 INION OTPS BIOABSORBABLE FREEDOMPLATE BONE PLATE HRS INION OY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention