BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR TITANIUM 3.0X12MM SK

    MDR report key: 25045779 · Received April 30, 2026

    Report

    Report Number
    3008650117-2026-00203
    Event Type
    Injury
    Date Received
    April 30, 2026
    Report Date
    April 30, 2026
    Manufacturer
    PARAGON 28
    Product Code
    MBI
    PMA / PMN Number
    K231867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: P44-111-3012-SK, SUTURE ANCHOR TITANIUM 3.0 X 12 MM SK, LOTS: 5011464 AND 5012765. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED POSTOPERATIVE INFECTION FOLLOWING THE TITANIUM ANCHOR PROCEDURE. APPROXIMATELY 2-3 WEEKS POST IMPLANTATION, THE SUTURES WERE REMOVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190168 SUTURE ANCHOR TITANIUM 3.0X12MM SK FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI PARAGON 28 5012765

    Patients

    Seq Age Sex Outcome Treatment
    1