BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2830057 · Received November 13, 2012

    Report

    Report Number
    1030489-2012-02111
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    April 19, 2013
    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.

    Description of Event or Problem · 1

    PATIENT HAD FALLEN 28 FEET ONTO CONCRETE SUSTAINING INJURY TO HIS BACK. PATIENT PRESENTED WITH PAIN IN HIS BACK RADIATING DOWN HIS LEFT LEG UNRESPONSIVE TO EPIDURAL FACET BLOCKS, MEDICATIONS, ACTIVITY MODIFICATION. PHYSICAL EXAMINATION DEMONSTRATED HE HAD DIMINISHED SENSATION IN THE L5 AND S1 DERMATOMAL DISTRIBUTIONS. HE HAD 4/5 LEFT _HL AND 4/5 LEFT PLANTAR FLEXION. HIS MRI DEMONSTRATED A SMALL LEFT L5-S1 HNP WITH FORAMINAL STENOSIS AND DEGENERATIVE DISK WITH LOSS OF DISK SPACE HIGH AND ENDPLATE CHANGE AT L5-S1. ON (B)(6) 2008 PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) USING ALPHATEC ZODIAC PEDICLE SCREW INSTRUMENTATION, NOVEL PEEK INTERBODY SPACER AT LEFT L5/S1, AUTOGRAFT FROM LEFT POSTERIOR ILIAC CREST, AND RHBMP-2/ACS OVER THE BONE GRAFT ON THE RIGHT AND ANTERIOR TO THE BONE GRAFT ON THE LEFT. ON (B)(6) 2008 PATIENT UNDERWENT CT SCAN FOR DECREASED BILATERAL LOWER EXTREMITY MOVEMENT STATUS POST PLIF. "THE PATIENT IS UNABLE TO MOVE HIS LOWER EXTREMITIES. NO MASS EFFECT IS SEEN ABOVE OR BELOW THE LEVEL OF THE DISC. UPPER LEVELS SHOW MILD DISC BULGING AT L4/5 AND L3/4, BUT NO OTHER ABNORMALITIES. NO CENTRAL CANAL OR FORAMINAL STENOSIS IS NOTED. THE GAS IN THE EPIDURAL SPACE IS I BELIEVE RELATED TO SURGERY.¿ ON (B)(6) 2011 PATIENT UNDERWENT CT SCAN. IMAGING IDENTIFIED SMALL POSTERIOR BONY SPRING OSTEOPHYTES PARTICULARLY AT L5-S1. FROM (B)(6) 2011 TO (B)(6) 2012 PATIENT WAS REPEATEDLY SEEN FOR FOLLOW UP FOR LOW BACK PAIN (LBP). SYMPTOMS INCLUDED "ACUTE EXACERBATION. LBP MODERATE TO SEVERE SHARP STABBING. PAIN RADIATES TO THE RIGHT LEG AND LEFT LEG. TREATED WITH MEDICATION. SYMPTOMS ASSOCIATED WITH BACK STIFFNESS AND PARESTHESIAS IN LEGS."

    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.

    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 M110705AAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R