BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM CANNULATED FASTENER

    MDR report key: 18302680 · Received December 11, 2023

    Report

    Report Number
    3011656326-2023-00010
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Report Date
    December 11, 2023
    Manufacturer
    OSTEOCENTRIC TECHNOLOGIES, INC.
    Product Code
    HWC
    PMA / PMN Number
    K211290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    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.

    Description of Event or Problem · 0

    SURGERY WAS PERFORMED ON A SUBACUTE PELVIC INJURY. A 7.0 CANNULATED FASTENER USED IN THE PROCEDURE WAS OBSERVED TO BE BACKED OUT AT AROUND THE SIX-WEEK POSTOPERATIVE MARK. THE FASTENER WAS RETIGHTENED AFTER THE INITIAL SURGERY BUT WAS OBSERVED TO BE BACKED OUT AGAIN AFTER TWO WEEKS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772657 7.0MM CANNULATED FASTENER HWC OSTEOCENTRIC TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other