BEUDAMED
    FDA Adverse Event Other Summary report: N

    2.5CC OSTEOSTRUX OSTEOCONDUCTIVE SCAFFOLD PUTTY

    MDR report key: 2093970 · Received April 26, 2011

    Report

    Report Number
    1121308-2011-00010
    Event Type
    Other
    Date Received
    April 26, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 26, 2011
    Manufacturer
    INTEGRA, PLAINSBORO
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGICAL PROCEDURE, THE PRODUCT THAT HAD PASSED ITS LABEL EXPIRATION DATE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.5CC OSTEOSTRUX OSTEOCONDUCTIVE SCAFFOLD PUTTY OSTEOSTRUX MQV INTEGRA, PLAINSBORO 105B00179675

    Patients

    Seq Age Sex Outcome Treatment
    1 Other