BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATELLAR TENDON HEMI

    MDR report key: 514483 · Received February 26, 2004

    Report

    Report Number
    MW1031359
    Event Type
    Malfunction
    Date Received
    February 26, 2004
    Date of Event
    December 30, 2003
    Report Date
    January 9, 2004
    Manufacturer
    REGENERATION TECHNOLOGIES
    Product Code
    LMO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STAT GRAM STAIN ON THE HEMI PATELLAR TENDON GRAFT WAS DONE DURING PREPARATION OF THE GRAFT FOR SURGERY. THIS WAS POSITIVE FOR RARE SMALL GRAM NEGATIVE RODS. GRAFT WAS TO BE USED FOR AN ANTERIOR CRUCIATE LIGAMENT REPAIR. CASE CANCELLED PRIOR TO SURGICAL INCISION AND GRAFT IMPLANTATION. NO ADVERSE PT OUTCOME; INCONVENIENCE TO PT AND FAMILY. CONTACTED DISTRIBUTING REP WHO CONTACTED THE SUPPLYING COMPANY, REGENERATION TECHNOLOGIES. HOSPITAL FINDINGS: STAT GRAM STAIN: POSITIVE FOR RARE NEGATIVE RODS. PRELIMINARY CULTURE FINDINGS: NO GROWTH IN 1 DAY. FINAL: NO GROWTH IN 7 DAYS. REGENERATION TECHNOLOGIES CONTACTED DEPT. MANAGER AND OBTAINED INFO ON THE OCCURRENCE. RECEIVED A RESPONSE FROM REGENERATION TECHNOLOGIES WITH THE FINAL ASSESSMENT FROM RTI BEING THAT THE PRESENCE OF NON-VIABLE ORGAINISMS ON THE TISSUE UPON GRAM STAIN WAS CELLULAR DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATELLAR TENDON HEMI SAME AS ABOVE LMO REGENERATION TECHNOLOGIES 2141923 101032500

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other