BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4153211 · Received October 8, 2014

    Report

    Report Number
    1030489-2014-03952
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    June 2, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    PER MEDICAL RECORDS, IT WAS REPORTED THAT ON (B)(6) 2011: PATIENT PRESENTED WITH PRE-OPERATIVE DIAGNOSIS OF L5-S1 ISTHMIC SPONDYLOSIS. PATIENT UNDERWENT L5-S1 TLIF USING RHBMP-2/ACS, SYNTHES CHRONOS(TM) BETA- TCP STRIP AND MUSCULOSKELETAL TRANSPLANT FOUNDATION T-PLIF SPACER. NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2012, PATIENT UNDERWENT CT EXAM OF THE LUMBAR SPINE WITHOUT CONTRAST DUE TO L5-S1 LUMBAR FUSION FOR SPONDYLOSIS. FINDINGS: THERE IS POSTERIOR TRANSPEDICULAR FUSION HARDWARE AND TLIF AT L5-S1 LEVEL. INTERBODY GRAFT IS PARTIALLY INCORPORATED INTO THE ENDPLATES. SCREWS WERE IN GOOD ALIGNMENT WITHOUT LOOSENING. THERE IS MINIMAL ANTEROLISTHESIS OF L5 IN RELATION TO S1. A LARGE LEFT PARACENTRAL SOFT TISSUE DENSITY IS PRESENT ALONG THE LEFT LATERAL RECESS AT L5-S1 LEVEL, ENCROACHING OVER THE TRAVERSING LEFT S1 NERVE ROOT. THIS COULD REPRESENT EITHER A LARGE LEFT PARACENTRAL DISC EXTRUSION OR AN ORGANIZING SMALL HEMATOMA ALONG THE SITE OF TLIF. A SYNOVIAL CYST AND A SCAR TISSUE ARE OTHER LESS LIKELY POSSIBILITIES. CENTRAL CANAL AND RIGHT LATERAL RECESSES ARE PRESERVED. CORONAL RECONSTRUCTIONS REVEAL COALESCING GRAFT MATERIAL ALONG THE POSTERIOR ELEMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630752 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111064AAQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other