BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM MATRIX PLF

    MDR report key: 3409956 · Received October 15, 2013

    Report

    Report Number
    2246640-2013-00024
    Event Type
    Injury
    Date Received
    October 15, 2013
    Date of Event
    January 9, 2013
    Report Date
    September 25, 2013
    Manufacturer
    OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)
    Product Code
    MBP
    PMA / PMN Number
    K051195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). ALL DONOR AND MANUFACTURING RECORDS RELATIVE TO THE SUBJECT GRAFT WERE REVIEWED AND INDICATED THAT THE GRAFT WAS MANUFACTURED ACCORDING TO PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS. THE DONOR TISSUE WAS CONFIRMED ELIGIBLE FOR TRANSPLANTATION BY THE MANUFACTURER'S MEDICAL DIRECTOR. THE TISSUE RECOVERY ORGANIZATION WHICH PROVIDED THE DONOR TISSUE TO THE MANUFACTURER WAS NOTIFIED OF THIS INCIDENT, AND THEY HAVE RECEIVED NO ADDITIONAL REPORTS OF INFECTION INVOLVING ANY OTHER TISSUES PROCURED FROM THIS DONOR. THE MANUFACTURER HAS NOT RECEIVED ANY OTHER REPORTS OF INFECTION INVOLVING ANY OTHER GRAFTS MANUFACTURED FROM THIS LOT OR FROM THIS DONOR TISSUE. BASED ON THESE FINDINGS, THE MANUFACTURER'S MEDICAL DIRECTOR HAS CONCLUDED THAT THERE IS NO MEDICAL EVIDENCE TO INDICATE THAT THE SUBJECT GRAFT CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. NO FURTHER ACTION IS DEEMED NECESSARY. THIS INCIDENT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION 3 WEEKS FOLLOWING A SPINAL DECOMPRESSION PROCEDURE IN WHICH DBM BONE VOID FILLER WAS IMPLANTED. PEDICLE SCREWS WERE PLACED AT L4 <(>&<)> L5, A LAMINECTOMY CARRIED OUT AT L3-L5. FOLLOWING THIS, THE HYPERTROPHIC LIGAMENTUM FLAVIUM WAS REMOVED, THE HYPERTROPHIC FACET JOINTS WERE SEVERELY THICKENED AND THE TRANSVERSING NERVE ROOTS WERE FOUND TO BE UNDER A THICK LAYER OF HYPERTROPHIC BONE AND OSTEOPHYTES. THESE WERE ALSO REMOVED. THE L5 PEDICLE SCREW WAS FOUND TO BREACH THE MEDIAL WALL AND THUS WAS REPLACED TO A MORE LATERAL POSITION. A SIMILAR PROCEDURE WAS CARRIED OUT AT L3-L4. THE SCREWS WERE CONNECTED BY 2 PEEK RODS AND SECURED. THE SURGICAL SITE WAS THOROUGHLY IRRIGATED. AUTOGRAFT MIXED WITH ALLOGRAFT DBM BONE VOID FILLER WAS THEN PLACED IN THE LATERAL GUTTERS BETWEEN THE TRANSVERSE PROCESSES AT L4-L5 AND COMPACTED MANUALLY. A HEMOVAC DRAIN WAS PLACED. APPROXIMATELY 3 WEEKS LATER, THE PATIENT PRESENTED TO LOCAL ER WITH AN ACUTE ONSET OF LOWER BACK PAIN RADIATING DOWN TO THE BUTTOCKS AND KNEES. PATIENT REPORTED SHE HAD BEEN AFEBRILE. INFLAMMATORY MARKERS WERE ELEVATED. PATIENT WAS READMITTED TO THE HOSPITAL THAT SAME DAY, AND AN INCISION AND DRAINAGE (I<(>&<)>D) WAS PERFORMED THE FOLLOWING DAY. IT WAS REPORTED THAT THE ORIGINAL INCISION WAS INCISED, AND A SMALL AREA OF DEHISCENCE WAS NOTED AT THE INFERIOR ASPECT OF THE WOUND. A SIGNIFICANT AMOUNT OF PURULENT DISCHARGE WAS ENCOUNTERED AT THE DEEP DERMAL LAYER, WHICH WAS CONNECTED TO A FASCIAL DEHISCENCE SUPERIORLY. NO PURULENT DRAINAGE NOTED FROM THE AREA OF THE L4/L5 DISC SPACE. SOME SURROUNDING NECROTIC TISSUE IN THE FATTY LAYER WAS DEBRIDED AND WOUND WAS IRRIGATED. ANTIBIOTIC BEADS WERE PLACED AS WELL AS A WOUND DRAIN. THE PATIENT WAS PLACED ON ANTIBIOTICS FOR 2 MONTHS DURING WHICH TIME THE WOUND HEALED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526877 GRAFTON DBM MATRIX PLF FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) MBP OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) A42200 OTSCT1108064035

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R