BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4203694 · Received October 27, 2014

    Report

    Report Number
    1030489-2014-04137
    Event Type
    Injury
    Date Received
    October 27, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2005, THE PATIENT UNDERWENT RETROPERITONEAL DECOMPRESSION; L4-S1 ANTERIOR DISCECTOMY WITH INTERBODY FUSION; L4-S1 ANTERIOR SEGMENTAL INSTRUMENTATION; USAGE OF RHBMP-2/ACS; AND L4-S1 POSTERIOR LATERAL INSTRUMENTED FUSION. ON 3/28/2006 THE PATIENT UNDERWENT L5-S1 LUMBAR LAMINECTOMY DISCECTOMY; L4-5 AND L5-S1 POSTERIOR LATERAL FUSION; L4-5 AND L5-S1 AND SEGMENTAL INSTRUMENTATION; AND LOCAL AUTOGENOUS BONE GRAFT; L4-5 AND L5-S1 ANTERIOR PARTIAL VERTEBRECTOMY; L4-5 AND L5-S1 ANTERIOR INTERBODY FUSION; L4-5 AND L5-S1 ANTERIOR SPINAL INSTRUMENTATION; AND LOCAL AUTOGENOUS BONE GRAFT RHBMP-2/ACS. ON (B)(6) 2007, THE PATIENT UNDERWENT ANTERIOR DISCECTOMY AND INTERBODY FUSION AT L3-4 ALONG WITH POSTERIOR ARTHRODESIS; ANTERIOR INTERBODY L3-4 FUSION; L3-L4 ANTERIOR BIOMECHANICAL CAGE APPLICATION; L3-4 ANTERIOR SPINAL INSTRUMENTATION; L3-4 LUMBAR LAMINECTOMY; L3-4 POSTERIOR LATERAL FUSION; L4-5 AND L5-S1 EXPLORATION OF FUSION; L4-5 AND L5-S1 REMOVAL OF HARDWARE; AND RE-INSTRUMENTATION L3-S1. SOMETIME POSTOP, THE PATIENT REPORTEDLY EXPERIENCED LOW BACK PAIN WHICH RADIATES INTO UPPER THIGH; ADJACENT LEVEL SEGMENT DISC DISEASE; ABDOMINAL PAIN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682459 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