BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM CANNULATED FASTENER

    MDR report key: 18401229 · Received December 27, 2023

    Report

    Report Number
    3011656326-2023-00015
    Event Type
    Malfunction
    Date Received
    December 27, 2023
    Date of Event
    December 11, 2023
    Report Date
    December 27, 2023
    Manufacturer
    OSTEOCENTRIC TECHNOLOGIES, INC
    Product Code
    HWC
    PMA / PMN Number
    K211290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION IS INCONCLUSIVE AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE MODEL NUMBER AND BATCH/LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    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

    AT THREE WEEKS POST-OP A VERTICAL BREAK WAS OBSERVED IN THE 7.0 CANNULATED FASTENER LOCATED IN THE ILIUM. THE INITIAL FRACTURE WAS THREE MONTHS OLD. THE FASTENER WAS PLACED ACCORDINGLY TO PROVIDE STABILITY. THE SURGEON DID NOT INDICATE THAT THE FASTENER NEEDED TO BE REMOVED BASED ON NOT CURRENTLY CAUSING ANY ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325696 7.0MM CANNULATED FASTENER HWC OSTEOCENTRIC TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other