BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOSELECT DBM PUTTY

    MDR report key: 2851244 · Received November 29, 2012

    Report

    Report Number
    3005168462-2012-00001
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    September 18, 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

    ADDITIONAL DEVICE INFO: LOT #: B110253-711, EXP DATE: 02/28/2014. BACTERIN REVIEWED PROCESSING CHARTS FOR THE IDENTIFIED PRODUCTS. ALL PRODUCT PRODUCED AND WERE TERMINALLY STERILIZED VIA GAMMA IRRADIATION AT THE FOLLOWING DOSE: B110129-718M (VALIDATED DOSE IS (B)(4)) - DELIVERED DOSE OF 11.2-12.8 KGY ON (B)(6) 2012. B110253-711 (VALIDATED DOSE IS (B)(4)) - DELIVERED DOSE OF 11.3-13.0 KGY ON (B)(6) 2012. B120154-327 (VALIDATED DOSE IS (B)(4)) - DELIVERED DOSE OF 22.2-25.3 KGY ON (B)(6) 2012. B120213-268 (VALIDATED DOSE IS (B)(4)) - DELIVERED DOSE OF 23.8-27.5 KGY ON (B)(6) 2012. ENDOTOXIN LEVELS WERE BELOW 20EU/DEVICE FOR BOTH OSTEOSELECT DBM PUTTY LOTS.

    Description of Event or Problem · 1

    ON (B)(6) 2012 - LUMBAR LAMINECTOMY, MEDIAL FACETECTOMY AND FORAMINOTOMY AT L4-L5 BILATERALLY. LUMBAR SPINOUS PROCESS FUSION, L4-L5, USING SPINAL FRONTIER INTERSPINOUS DEVICE. PREPARATION OF THE BONE FOR ARTHRODESIS. BONE ARTHRODESIS L3, L4 AND L5. PROCEDURE WAS PERFORMED IN RESPONSE TO PT BACK AND LEG PAIN. ON (B)(6) 2012 - PT WAS DIAGNOSED WITH DRAINAGE OF LUMBAR WOUND. THE WOUND WAS DEBRIDED, IRRIGATED AND THE SEROMA WAS DRAINED ALONG WITH PLACEMENT OF A SUBCUTANEOUS DRAIN. SURGEON STATED THAT THE DBM PUTTY HAD EXTRUDED INTO THE SUBCUTANEOUS SPACE ALONG WITH A CLEAR FLUID. THE SURGEON DID NOT NOTICE ANY FASCIAL DISRUPTION. EXTRUDED PUTTY WAS REMOVED. ON (B)(6) 2012 - PT RETURNED TO FACILITY TO HAVE THE DRAIN REMOVED. RESIDUAL DRAINAGE WAS EXPRESSED OUT. PHYSICIAN'S REPORT RECEIVED ON (B)(4) 2012, STATED THAT THE DBM PUTTY HAD "SQUEEZED THROUGH" THE FASCIA INTO SUBCUTANEOUS SPACE AND WAS ACTING AS AN IRRITANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOSELECT DBM PUTTY NONE MQV BACTERIN NA B110129-718

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization EXP = 06/14/2017| SPINAL FUSION DEVICE| HIGH SPEED DRILL| BACTERIN OSTEOSPONGE FILLER: (B)(4), 10.0CC,| BACITRACIN SOLUTION| OSTEOSPONGE FILLER: (B)(4), 10.0CC,| INTERSPINAL DILATOR| EXP = 06/01/2017