BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3316030 · Received August 29, 2013

    Report

    Report Number
    1030489-2013-03728
    Event Type
    Injury
    Date Received
    August 29, 2013
    Report Date
    November 30, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT PRESENTED WITH L5-S1 ISTHMIC SPONDYLOLISTHESIS WITH L5 ROOT STENOSIS. PATIENT UNDERWENT LUMBAR DECOMPRESSION WITH LAMINECTOMY L5, FORAMINOTOMIES L5-S1 BILATERALLY, L5-S1 FUSION WITH TLIF CAGE PLUS LOCAL AUTOGRAFT, AND POSTEROLATERAL FUSION WITH LOCAL AUTOGRAFT PLUS ALLOGRAFT PLUS RHBMP-2 AND 3D PEDICLE INSTRUMENTATION. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT PRESENTED WITH THE FOLLOWING DIAGNOSIS: L5-S1 ISTHMIC SPONDYLOLISTHESIS WITH L5 ROOT STENOSIS. SHE UNDERWENT THE FOLLOWING PROCEDURES: LUMBAR DECOMPRESSION WITH LAMINECTOMY L5. FORAMINOTOMIES L5-S1 BILATERALLY. L5-S1 FUSION WITH TRANSFORAMINAL LUMBAR INTERBODY FUSION CAGE PLUS LOCAL AUTOGRAFT. POSTEROLATERAL FUSION WITH LOCAL AUTOGRAFT PLUS BONE MORPHOGENIC PROTEIN AND 3D PEDICLE INSTRUMENTATION. PER OP NOTES: LAMINECTOMY OF L5 WITH A LOOSE POSTERIOR ELEMENT WAS PERFORMED. KERRISON RONGEURS WERE USED TO REMOVE LOOSE INFERIOR FACET JOINTS. FORAMINOTOMY OF LEFT AND RIGHT L5 ROOT WAS PERFORMED. SOME BONE GRAFT WAS PLACED ANTERIORLY AND LATERALLY USING LOCAL AUTOGRAFT. THEN SOME BONE WAS PACKED IN A 22 X 10 MM PEEK CAGE AND CAREFULLY TAPPED IN TOWARD THE MIDLINE. NICE DISTRACTION WAS OBTAINED. THEN PEDICLE SCREWS WERE PLACED AT THE L5 PEDICLES BILATERALLY. ALLOGRAFT PLUS LOCAL AUTOGRAFT PLUS A MEDIUM BONE MORPHOGENIC PROTEIN SPONGES WERE PACKED BETWEEN L5 AND S1 OVER THE TRANSVERSE PROCESSES AND THE ALA. A 3D PEDICLE INSTRUMENTATION WAS PLACED TO CONNECT THE SCREWS AND GENTLY COMPRESS DOWN THE WITH TRANSFORAMINAL LUMBAR INTERBODY FUSION C AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426464 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other