BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEXUR M

    MDR report key: 2160479 · Received July 6, 2011

    Report

    Report Number
    2246640-2011-00012
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 15, 2011
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQV
    PMA / PMN Number
    K073405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS TERMINALLY STERILIZED (B)(4). HOWEVER, WITHOUT ADD'L DEVICE INFO, A REVIEW OF MFG RECORDS AND STERILIZATION CERTIFICATION WAS NOT POSSIBLE. WITH THE LIMITED INFO, WE COULD NOT DEFINITIVELY CONFIRM WHETHER THE REPORTED EVENT WAS OR WAS NOT ASSOCIATED WITH THE IMPLANT.

    Description of Event or Problem · 1

    IN AN E-MAIL TO MARKETING PERSONNEL SUGGESTING HOW THE PRODUCT COULD BE IMPROVED BY CONTAINING ANTIBIOTICS, THE SURGEON REPORTED THAT A PT OF HIS, IN WHOM HE HAD IMPLANTED THE PRODUCT, HAD DEVELOPED A POST-OPERATIVE INFECTION. THE PHYSICIAN STATED THAT HE DID NOT ATTRIBUTE THE INFECTION TO THE GRAFT, BUT RATHER TO THE INJURY TYPE HAVING A HIGH INFECTION RATE (OPEN FEMUR FRACTURE). MULTIPLE UNSUCCESSFUL REQUESTS WERE MADE FOR THE PRODUCT LOT INFO AND DETAILS OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXUR M RESORBABLE BONE VOID FILLER MQV OSTEOTECH, INC. NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention