BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUPINE ANCHOR W/ORTHOCORD

    MDR report key: 1153086 · Received September 8, 2008

    Report

    Report Number
    1221934-2008-00435
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 27, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD IS NOT BEING RETURNED TO DEPUY MITEK; THEREFORE, AN EVAL CANNOT BE PERFORMED AT THIS TIME, AND NO OTHER INFO HAS BEEN PROVIDED SUCH AS CULTURE RESULTS BY THE INSTITUTION AT THIS TIME. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PROD COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PROD WAS PROCESSED WITHOUT INCIDENT, AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. BASED ON THE INFO PROVIDED TO DATE, NO OTHER ROOT-CAUSE COULD BE DETERMINED. THE SURGERY CENTER NOTIFIED MITEK AS A COURTESY, TI WAS NOTED THE DR AND FACILITY ARE NOT QUESTIONING THE MITEK PRODS. THE PURPOSE OF THIS MEDWATCH IS TO DOCUMENT THE EVENT. NO FURTHER ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    IN 2008, THESE IMPLANTS WERE USED IN CONJUNCTION WITH A GRAFT JACKET (WHICH WAS NOT A MITEK DEVICE). ON THIRTEEN DAYS LATER, THE GRAFT JACKET AND ANCHORS WERE REMOVED DUE TO AN INFECTION. VICRYL WAS USED TO SUTURE THE JACKET, AND THE PT REPORTED ACNE ON HIS BACK WHICH WAS THE SAME BACTERIUM FOUND AT THE SURGICAL SITE. THE SURGERY CENTER NOTIFIED MITEK AS A COURTESY, BUT THE DR AND FACILITY ARE NOT QUESTIONING THE MITEK PRODS. PLEASE ALSO SEE 1221934-2008-00433, 00434 & 00436.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUPINE ANCHOR W/ORTHOCORD SOFT TISSUE FIXATION DEVICE MAI DEPUY MITEK 0710096

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK