BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY

    MDR report key: 10872245 · Received November 19, 2020

    Report

    Report Number
    3005031160-2020-00033
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Date of Event
    October 21, 2020
    Report Date
    November 19, 2020
    Manufacturer
    XTANT MEDICAL
    Product Code
    MBP
    UDI-DI
    00849777003681
    PMA / PMN Number
    K130498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY ROUTINELY ISSUES COMMUNICATIONS REGARDING EXPIRING PRODUCT TO SALES PERSONNEL. THIS COMMUNICATION INCLUDES A LIST OF SERIAL NUMBERS AND LOCATIONS FOR EXPIRING PRODUCT. THIS LIST IS INTENDED TO BE USED BY THE SALES REPRESENTATIVES TO ENSURE THAT EXPIRING PRODUCT IS APPROPRIATELY DISCARDED. AN EXPIRING TISSUE FIELD NOTIFICATION WAS EMAILED TO SALES PERSONNEL ON 01/03/2020, WHICH INCLUDED THE EXPIRATION DATE (04/04/2020), AND LOCATION OF THE COMPLAINT GRAFT. THIS GRAFT HAD BEEN AT THE SURGICAL FACILITY SINCE 06/14/2018. THE COMPLAINANT RECEIVED THE EXPIRING TISSUE FIELD NOTIFICATION FROM THE COMPANY ON 1/03/2020. THE GRAFT WAS NOT APPROPRIATELY DISCARDED OR RETURNED TO THE COMPANY AS INSTRUCTED.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED NOTIFICATION ON 10/21/2020 FROM A SALES DISTRIBUTOR THAT A COMBINATION PRODUCT GRAFT HAD BEEN IMPLANTED BEYOND THE EXPIRATION DATE IDENTIFIED ON THE PRODUCT PACKAGE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS REPORT OF AN IMPLANTED EXPIRED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336430 OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY BONE VOID FILLER MBP XTANT MEDICAL 359100 00849777003681

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other