BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOSTINGER MENISCAL REPAIR DEVICE

    MDR report key: 238300 · Received August 27, 1999

    Report

    Report Number
    1017294-1999-00034
    Event Type
    Other
    Date Received
    August 27, 1999
    Date of Event
    July 25, 1999
    Report Date
    July 27, 1999
    Manufacturer
    LINVATEC CORP.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BIOSTINGER BROKE IN THE PT'S BODY. PT HAD AN ACL WITH MED MENISCAL REPAIR PERFORMED ON 05/25/1999 UTILIZING SEVERAL 'ARROWS'(BIOSTINGERS). ON 06/11/1999 PT COMPLAINED OF A SMALL, SHARP PAINFUL AREA THAT 'FEELS LIKE A PIN' IN THE OPERATIVE KNEE. THIS WAS ALSO PALPABLE. ON 07/25/1999 PT RETURNED TO SURGERY FOR EXCISION OF 'ARROW'. SUPERFICIAL INCISION WAS MADE, 'ARROW' WAS EASILY EXCISED, SINGLE STITCH REQUIRED FOR CLOSURE. DR. STATED 'ARROW APPARENTLY MIGRATED OUT OF THE KNEE AND LOOKED LIKE THE BIOSTINGER WAS WORN, NOT BROKEN'. FOUR BIOSTINGER REPAIR DEVICE'S WERE USED ON INITIAL SURGERY 05/25/1999. IT IS UNK WHICH ON EMIGRATED OUT AND WAS REMOVED ON THE 07/25/1999 SURGICAL PROCEDURE. THE LOT NUMBER'S INITIALLY IMPLANTED-00131218 X 2, 00130042 X 1, 00127787 X 1. SINCE THE ACTUAL LOT NUMBER IS UNK, ONE OF THE LOT NUMBERS WAS PICKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTINGER MENISCAL REPAIR DEVICE Implant MENISCAL REPAIR DEVICE HWC LINVATEC CORP. NA 00131218

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other