BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAGEL 4.5ML

    MDR report key: 3090873 · Received May 2, 2013

    Report

    Report Number
    0002530131-2013-00001
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    LMF
    PMA / PMN Number
    P050044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED FOLLOWING SURGICAL PROCEDURE, NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON OBSERVED REDNESS FOLLOWING AN LAMINECTOMY L4-L5 TRANSVERSE. SURGEON TREATED PATIENT WITH: DEBRIDEMENT OF THE SURGICAL SITE, STEROIDS, ANTIHISTAMINES, AND CULTURES. THE CULTURES CAME BACK NEGATIVE CONCLUDING THAT THERE WAS NO INFECTION WITH THIS EVENT. THE SURGEON IS CONFIDENT THAT THIS WAS AN ALLERGIC REACTION, THAT MAY OR MAY NOT HAVE BEEN CAUSED BY VITAGEL. THIS EVENT WILL BE REPORTED SINCE IT IS CANNOT BE CONCLUDED WHETHER OR NOT VITAGEL CONTRIBUTED TO THE ALLERGIC REACTION. FURTHERMORE, THE PATIENT IS EXPECTED TO MAKE A COMPLETE RECOVERY. A COMPREHENSIVE DEVICE HISTORY REVIEW WAS PERFORMED. THERE WERE NO ANOMALIES IDENTIFIED IN THIS REVIEW, THE DEVICE SATISFIED ALL QC RELEASE CRITERIA. ADDITIONALLY, MICROBIOLOGY TESTING AND ENVIRONMENTAL MONITORING PRODUCED PASSING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191888 VITAGEL 4.5ML VITAGEL LMF STRYKER ORTHOBIOLOGICS-MALVERN A1301012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other