BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSTEOSELECT DBM PUTTY

    MDR report key: 3772098 · Received April 3, 2014

    Report

    Report Number
    3005168462-2014-00008
    Event Type
    Other
    Date Received
    April 3, 2014
    Date of Event
    December 23, 2013
    Report Date
    April 2, 2014
    Manufacturer
    BACTERIN INTERNATIONAL, INC.
    Product Code
    MQV
    PMA / PMN Number
    K091321
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L DEVICE MANUFACTURE DATE: 11/2012.

    Description of Event or Problem · 1

    BACTERIN WAS NOTIFIED ON (B)(6) 2014 OF 19 CASES PERFORMED BY A SURGEON THAT RESULTED IN POST-OP SEROMA FORMATION. BACTERIN PRODUCTS, OSTEOSPONGE AND/OR OSTEOSELECT DBM PUTTY HAD BEEN USED IN 10 OF THE 19 CASES. THE CASES OCCURRED AT TWO FACILITIES. ONE OF THESE FACILITIES IS INVESTIGATING THE HIGH RATE OF I&D ADMITS FOR THIS SURGEON. IT WAS NOTED BY THE INITIAL RPTR THAT THE PHYSICIAN USES A CLOSURE TECHNIQUE THAT ALLOWS "DEAD SPACE" WHICH MAY FACILITATE SEROMA FORMATION. THIS SURGEON HAS PREVIOUSLY REPORTED POST OP SEROMA FORMATION USING BACTERIN PRODUCTS. HISTORICAL EVALUATIONS OF POTENTIAL ADVERSE REACTIONS REPORTS REC'D BY BACTERIN SINCE (B)(6) 2011 (INCLUDING THESE 10 RECENTLY REC'D) SHOW THAT THIS PHYSICIAN WAS INVOLVED IN 68% OF THE CASES. BACTERIN HAS NOT REC'D ANY OTHER REPORTS OF POTENTIAL ADVERSE REACTIONS RESULTING FROM THE USE OF OSTEOSPONGE PRODUCTS. ALL BACTERIN PRODUCTS ARE PROVIDED STERILE VIA EXPOSURE TO A VALIDATED GAMMA IRRADIATION DOSE IN THE FINAL PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203045 OSTEOSELECT DBM PUTTY MQV, MBP MQV BACTERIN INTERNATIONAL, INC. 309100 B120305-DBM

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other 309100, B120332-DBM, B120332-706: EXP 11/14/2014| OSTEOSPONGE FILLER 10.0CC: LOT # B130343-OST,| OSTEOSPONGE FILLER 10.0CC: LOT # B120496-OST| EXP DATE 11/18/2018, B130343-245| EXP DATE 03/13/2018, B120496-233