BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ALPHA RETROGRADE NAIL

    MDR report key: 16188755 · Received January 17, 2023

    Report

    Report Number
    0009610622-2023-00012
    Event Type
    Injury
    Date Received
    January 17, 2023
    Date of Event
    December 22, 2022
    Report Date
    February 23, 2023
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE DISREGARD THE MFR REPORT #0009610622-2023-00012 PLEASE NOTE THAT THIS EVENT IS DUPLICATE OF STRYKER REPORT MFR. REPORT #0009610622-2023-00026 STRYKER (B)(4).

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE HAS NOT BEEN EXPLANTED YET.

    Description of Event or Problem · 0

    AS REPORTED: "ALPHA RETRO NAIL BENT MID SHAFT AT FRACTURE AFTER NWB FOR 3 MONTHS. WALKED ON LEG/NAIL FOR SEVERAL WEEKS AND BENT."

    Description of Event or Problem · 0

    AS REPORTED: "ALPHA RETRO NAIL BENT MID SHAFT AT FRACTURE AFTER NWB FOR 3 MONTHS. WALKED ON LEG/NAIL FOR SEVERAL WEEKS AND BENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203563 UNKNOWN ALPHA RETROGRADE NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention