BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM VARIABLE THREAD CANNULATED FASTENER

    MDR report key: 18288441 · Received December 7, 2023

    Report

    Report Number
    3011656326-2023-00007
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 15, 2021
    Report Date
    December 7, 2023
    Manufacturer
    OSTEOCENTRIC TECHNOLOGIES, INC.
    Product Code
    HWC
    PMA / PMN Number
    K211290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON INDICATED THAT THE PATIENT HAD COMPLETELY HEALED AND THERE IS NO FURTHER ACTIVITY REQUIRED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER UPDATES, & REPORT SOURCE UPDATE: THIS REPORT UPDATES THE INITIAL REPORTER INFORMATION TO THE PHYSICIAN WHO INITIALLY REPORTED THE ISSUE AND INCLUDES THE REPORT SOURCE OF HOW THE ISSUE BECAME KNOWN BY OSTEOCENTRIC TECHNOLOGIES, INC.

    Description of Event or Problem · 0

    A PERCUTANEOUS PINNING OF THE RIGHT SACRAL FRACTURE WAS PERFORMED ON (B)(6) 2021 DURING THE FOLLOW UP APPOINTMENT ON (B)(6) 2021 IT WAS OBSERVED VIA X-RAY THAT THE 7.0MM VARIABLE THREAD CANNULATED FASTENER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220658 7.0MM VARIABLE THREAD CANNULATED FASTENER HWC OSTEOCENTRIC TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other