BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL RADIUS PLATE, DORSAL (R), 9 HOLES

    MDR report key: 10454039 · Received August 26, 2020

    Report

    Report Number
    3009996260-2020-00001
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    October 16, 2016
    Report Date
    August 25, 2020
    Manufacturer
    FLOWER ORTHOPEDICS CORPORATION
    Product Code
    HRS
    UDI-DI
    00840118103923
    PMA / PMN Number
    K142306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE BROKEN PLATE WAS NOT RECEIVED FOR ANALYSIS, FLOWER ORTHOPEDICS WAS UNABLE TO FULLY EVALUATE THE FAILURE MODE OF THE PLATE. THE SURGEON SUGGESTED THAT THE FAILURE OF THE PLATE MAY HAVE BEEN DUE TO PATIENT NON-COMPLIANCE (E.G., LIFTING A HEAVY OBJECT) DURING THE HEALING PROCESS BEFORE THE BONE HAD FULLY HEALED.

    Description of Event or Problem · 1

    COMPANY BECAME AWARE OF A DEVICE MALFUNCTION OF A CASE THAT OCCURRED IN 2016 ON (B)(6) 2020. THE SURGEON UTILIZED A DISTAL RADIUS PLATE, DORSAL (R), 9 HOLES TO FIX A FRACTURED DISTAL RADIUS. A COUPLE WEEKS AFTER SURGERY, THE PATIENT CAME BACK TO THE DOCTOR'S OFFICE, WITH PAIN, TO DISCOVER HE HAD REFRACTURED HIS WRIST AND THE PLATE HAD BROKEN IN HALF AT ONE OF THE MIDSHALF SCREW HOLES. THE SURGEON OPERATED AGAIN TO FIX THE BROKEN WRIST. HE REMOVED THE BROKEN HARDWARE AND USED A SIMILAR PLATE FROM ANOTHER COMPANY TO DO THE REVISION. THE PATIENT HAD NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922302 DISTAL RADIUS PLATE, DORSAL (R), 9 HOLES PLATE, FIXATION, BONE HRS FLOWER ORTHOPEDICS CORPORATION N/A N/A 00840118103923

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other