BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOSELECT DBM PUTTY

    MDR report key: 2851245 · Received November 29, 2012

    Report

    Report Number
    3005168462-2012-00003
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    August 16, 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

    (B)(4) WAS EXPOSED TO A TERMINAL GAMMA IRRADIATION DOSE OF (11.2-13.1 KGY) ON (B)(6) 2011. THE DOSE EXCEEDED THE VALIDATED STERILIZATION DOSE OF 9.0 KGY FOR THE PRODUCT.

    Description of Event or Problem · 1

    ON (B)(6) 2012 - LUMBAR LAMINOTOMY, MEDIAL FACETECTOMY, AND FORAMINOTOMY L3-4, L4-5 AND L5-S1 BILATERALLY. LUMBAR FACET FUSION L3-4 BILATERALLY. LUMBAR INTERSPINOUS FUSION L4-5. PREPARATION OF THE BONE FOR INTERSPINOUS FUSION. ON (B)(6) 2012 - ADMITTED FOR PAIN 10/10 RATING. SURGICAL SCAR AND STAPLES LOOK INTACT. NO DISCHARGE OR SUPPURATION. ASSESSED AS MULTI-LEVEL FACET ARTHROPATHY, STENOSIS AND HERNIATED LUMBAR DISC L5-S1. SCHEDULED EXPLORATORY SURGERY FOR (B)(6) 2012. ON (B)(6) 2012 - RE-EXPLORATION AND REMOVAL OF PREVIOUS FUSION. EXTENSION OF LUMBAR LAMINOTOMY, MEDIAL FACETECTOMY AND FORAMINOTOMY L3-4 AND L4-5. RE-FUSION OF L3-4 WITH INTERSPINOUS DEVICE. PUTTY REMOVED. ON (B)(6) 2012 - PT REPORTED THAT THE WOUND WAS "LEAKING" AND WAS DIAGNOSED WITH AN INFECTION. AN ANTIBIOTIC WAS PRESCRIBED. ON (B)(6) 2012 - FOLLOW-UP STATED THE "MAJORITY OF THIS PROBLEM HAD BEEN RESOLVED." ON (B)(6) 2012 REPORT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOSELECT DBM PUTTY NA MQV BACTERIN NA B090061-706

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization 0-VICRYL AND 2-0 VICRYL| SELF RETAINING EXTRACTORS| HIGH SPEED DRILL| KERRISON PUNCHES| BACITRACIN SOLUTION| SPATULAS| ILIAC CREST BONE| CERVICAL SCREWS| SURGEON MENTIONED A DOWEL.| K-WIRES| BONE FROM BONE-BANK