BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOSTEOSELECT DBM PUTTY

    MDR report key: 2851246 · Received November 29, 2012

    Report

    Report Number
    3005168462-2012-00002
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    September 24, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BACTERIN
    Product Code
    MQV
    PMA / PMN Number
    K091321
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BACTERIN REVIEWED PROCESSING CHARTS FOR THE IDENTIFIED PRODUCTS. ALL GRAFTS WERE TERMINALLY STERILIZED VIA GAMMA IRRADIATION AT THE FOLLOWING DOSES, WHICH MET THE MINIMUM VALIDATED STERILIZATION DOSE OF (B)(4) FOR OSTEOSELECT DBM PUTTY AND (B)(4) FOR OSTEOSPONGE AND BACFAST PRODUCTS. B120213-287 = DELIVERED DOSE OF 23.8 - 27.5 KGY ON (B)(6) 2012. B110225-512 = DELIVERED DOSE OF 21.3 - 24.9 KGY ON (B)(6) 2012. B110220-702 = DELIVERED DOSE OF 11.1 - 12.4 KGY ON (B)(6) 2011. B120146-532 = DELIVERED DOSE OF 21.3 - 24.9 KGY ON (B)(6) 2012. B120057-574 = DELIVERED DOSE OF 21.3 - 24.9 KGY ON (B)(6) 2012.

    Description of Event or Problem · 1

    ON (B)(6) 2012 - BILATERAL L4-L5 AND L5-S1 FACET FUSION WITH PLACEMENT OF L4-L5 SPINOUS PROCESS DEVICE. BILATERAL L4-L5 AND L5-S1 FORAMINOTOMIES. ON (B)(6) 2012 - PT FOLLOW UP AND REHAB REVEALED DRAINAGE OF WOUND AREA. PT COMPLAINED OF SEVERE LOW BACK PAIN. WOUND DEHISCENCE WAS NOTED. STATEMENT ON REPORT THAT THE PT "NEVER HAD INCISION COVERED". ON (B)(6) 2012 - WOUND WAS DEBRIDED AND A DRAIN WAS PLACED. ANTIBIOTICS WERE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOSTEOSELECT DBM PUTTY NA MQV BACTERIN NA B110220-702

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization KERRISON RONGEURS| 0 VICRYL POP-OFF SUTURES| BACFAST HD FACET DOWEL, 5 MM: B120057-574,| CURETTES| BACFAST HD FACET DOWEL, 5 MM: B110225-512,| 100511, EXP = 04/25/2017| FACET TUBES| JOINT WIRE| 100511, EXP = 04/25/2017| HIGH SPEED DRILL| OSTEOSPONGE FILLER, 10.0 CC: B120213-287,| 10MM SPINAL FRONTIER SPINOUS PROCESS DEVICE| BACFAST HD FACET DOWEL, 5 MM: B120146-532,| FACET DOWEL| 100511, EXP = 04/25/2017| 109510, EXP = 06/14/2017| 100511, EXP = 04/25/2017| BACFAST HD FACET DOWEL, 5 MM: B120146-536,| TORQUE WRENCH SCREWDRIVER| ANTIBIOTIC SOLUTION| DILATING TOOL