BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO SCRW,TI,3.5MMX 12MM

    MDR report key: 7890144 · Received September 19, 2018

    Report

    Report Number
    1220246-2018-00656
    Event Type
    Injury
    Date Received
    September 19, 2018
    Date of Event
    August 8, 2018
    Report Date
    September 19, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867131934
    PMA / PMN Number
    K111253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    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 DEVICE DISPOSITION WAS UNKNOWN BY THE REPORTER. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    DURING SOCIAL SAFEGUARD CYBER REVIEW (ARTHREX CHATTER COMMUNITY) A POTENTIAL DEVICE ISSUE WAS DISCOVERED. UPON FURTHER INVESTIGATION IT WAS CONFIRMED ON (B)(6) 2018 THAT A REVISION PROCEDURE HAD TAKEN PLACE. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION OBTAINED 9/5/2018: A PATIENT HAD A DISTAL RADIUS FRACTURE PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE THE FOLLOWING DEVICES WERE IMPLANTED: AR-8916VNL-03 LOT 10183688 (QTY 1), AR-8724V-20 (QTY 4 LOT UNKNOWN), AR-8935L12 (QTY 1 LOT UNKNOWN), AR-8935L-14 (QTY 1 LOT UNKNOWN), AND AR-8935-12 (QTY1 LOT UNKNOWN). THE PATIENT SUFFERED A FALL AND HAD A REVISION PROCEDURE ON (B)(6) 2018. DURING THE REVISION PROCEDURE ALL OF THE ORIGINAL IMPLANTS WERE REMOVED AND REPLACED. THE FOLLOWING DEVICES WERE IMPLANTED TO COMPLETE THE PROCEDURE: AR-8916VNL-03 LOT 10189728 (QTY1), AR-8724V-18 (QTY1 LOT UNKNOWN), AR-8724V-22 (QTY 3 LOT UNKNOWN), AR-8935L-12 (QTY1 LOT UNKNOWN), AR-8935L-14 (QTY 1 LOT UNKNOWN), AND AR-8935-12 (QTY1 LOT UNKNOWN). PER REPORTER IT IS UNKNOWN WHEN THE PATIENTS PAIN BEGAN OR IF PATIENT HAD ANY OTHER SYMPTOMS PRIOR TO THE PATIENT'S FALL. NO CULTURES WERE TAKEN OR ANY OTHER PROBLEMS FOUND DURING REVISION SURGERY. THE EXPLANTED DEVICES ARE NOT AVAILABLE TO RETURN AS THE DEVICE DISPOSITION IS UNKNOWN BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729036 LO-PRO SCRW,TI,3.5MMX 12MM PLATE, FIXATION, BONE HRS ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 12MM UNKNOWN 00888867131934

    Patients

    Seq Age Sex Outcome Treatment
    1 Other