BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2830094 · Received November 13, 2012

    Report

    Report Number
    1030489-2012-02125
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    July 11, 2018
    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)(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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT HAS DEVELOPED PAIN, VISITS DOCTOR FREQUENTLY, AS WELL AS CONSTANT ANGUISH THAT THINGS MIGHT GETWORSE.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: SPONDYLOLISTHESIS L5-S1 WITH L5 RADICULOPATHY BILATERALLY THE PATIENT UNDERWENT THE FOLLOWING PROCEDURE: LAMINECTOMY OF L4 TO S1; FASCIECTOMY L4-5, L5-S1; DISCECTOMY L4-5; L4-5 ¿ S1 PEDICLE SCREW FIXATION WITH SPONDYLOSIS REDUCTION SET; SPONDYLOSIS REDUCTION L5-S1; INTERTRANSVERSE FUSION L5-S1, POSTERIOR LUMBAR INTERBODY FUSION WITH PEEK SPACERS AND BONE MORPHOGENIC PROTEIN AT L5-S1; PLACEMENT OF EPIDURAL CATHETER. AS PER OPERATIVE NOTES,¿ WE HELD THIS IN PLACE WITH THE APPROPRIATE SCREWS AND THEN I DISTRACTED AND PLACED A 9MM PEEK SPACER WITH BONE MORPHOGENIC PROTEIN IN THIS. I COUNTERSUNK THIS WELL ON THE LEFT AND THEN ON THE RIGHT AND THIS WAS DONE WITH CAREFUL NERVE ROOT PROTECTION. ¿NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110609AAG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other