BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR TITANIUM 3.0X12MM SK

    MDR report key: 25043236 · Received April 30, 2026

    Report

    Report Number
    3008650117-2026-00197
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 29, 2026
    Manufacturer
    PARAGON 28
    Product Code
    MBI
    PMA / PMN Number
    K231867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. P44-111-3012-SK, SUTURE ANCHOR TITANIUM 3.0X12MM SK, LOT 5011464. 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 MONTHS POST IMPLANTATION, AN INCISION AND DRAINAGE WAS PERFORMED AND ANCHORS REMOVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101348 SUTURE ANCHOR TITANIUM 3.0X12MM SK FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI PARAGON 28 5010635

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R SEE H11