BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LO-PRO STR PLT,3.0MM5 HOLE,TI

    MDR report key: 11947271 · Received June 7, 2021

    Report

    Report Number
    1220246-2021-03217
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 17, 2021
    Report Date
    January 5, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867055049
    PMA / PMN Number
    K150456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAIN NOT CONFIRMED AS NO ALLEGATIONS WERE PROVIDED. IT IS UNKNOWN WHY THE PLATE WAS EXPLANTED. THE PLATE WAS FOUND TO BE BENT AND THE LOCKING THREADS WERE DAMAGED. 6 SCREWS WERE RETURNED WITH DAMAGED THREADS AND DRIVE FEATURES.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REMOVED FROM THE PATIENT. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2020 FOR A R MRJ FUSION; PER THE REPORTER THE REMOVAL WAS VOLUNTARY. NO MORE INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841641 LO-PRO STR PLT,3.0MM5 HOLE,TI PLATE, FIXATION, BONE HRS ARTHREX, INC. LO-PRO STR PLT,3.0MM5 HOLE,TI 5261927 00888867055049

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other