BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3031591 · Received April 2, 2013

    Report

    Report Number
    1030489-2013-00920
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    May 28, 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

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE USED 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. (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES OR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THIS CASE HAS BEEN DETERMINED TO BE A DUPLICATE OF 1030489-2013-00519. PLEASE SEE MEDWATCH REPORT NUMBER 1030489-2013-00519 FOR ALL DETAILS PERTAINING TO THIS CASE.

    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

    ON (B)(6) 2006 ¿ PT UNDERWENT PROCEDURE FOR LEFT L4 HEMILAMINOTOMY, L2-L5 POSTEROLATERAL FUSION WITH PEDICLE SCREW FIXATION, TLIF L3-4 AND L4-5 WITH PEEK SPACER. CENTRAL PORTION OF THE PEEK SPACERS WERE PACKED WITH INFUSE AND CANCELLOUS AUTOGRAFT. POSTEROLATERAL GUTTERS WERE PACKED WITH AUTOGRAFT, ALLOGRAFT, AND INFUSE. ON (B)(6) 2006 ¿ ¿HE STILL IS IN CONSIDERABLE PAIN.¿ ON (B)(6) 2006 - HE IS AFEBRILE. HIS BACK PAIN IS MARKEDLY IMPROVED, AS WELL AS HIS GROIN PAIN. HE CONTINUES TO STRUGGLE WITH HIS ANTERIOR THIGH PAIN. HE HAS SOME WEAKNESS ON LEFT FLEXION. HE STATES PUTTING PAIN ON HIS LEG DOES NOT APPEAR TO CAUSE WORSENING OF HIS LEFT ANTERIOR THIGH PAIN. HE HAS NO NEUROLOGIC SYMPTOMS OTHERWISE AND HIS FEMORAL NERVE IS NON-TENDER AND THE SCIATIC NOTCH IS NON-TENDER.¿ ON (B)(6) 2006 ¿ LUMBAR CT SHOWS ¿BIPEDICULAR SCREWS L2, L3, L4, AND L5 ARE NOTED AND APPEAR UNCOMPLICATED. THERE IS APPROXIMATELY 1 CM OF RETROLISTHESIS AT L2-3.¿ ON (B)(6) 2006 ¿ PT PRESENTS TO PHYSICAL THERAPY EVALUATION. ¿HE STATES THAT THE SURGERY HAS HELPED WITH HIS SEVERE SYMPTOMS, HOWEVER HE CONTINUES TO STRUGGLE WITH NUMBNESS AROUND HIS SURGERY SITE, AND WORSENING PAIN IN HIS BACK WITH PROLONGED STANDING OR WALKING.¿ ON (B)(6) 2007 ¿ LUMBAR CT SHOWS ¿THERE ARE MARKED POSTOPERATIVE AND CHRONIC-APPEARING CHANGES. THERE IS RETROLISTHESIS OF L2 ON L3. SPINAL STENOSIS DOES NOT APPEAR TO BE PRODUCED.¿ ON (B)(6) 2007 ¿ PT. ¿STATES HE CONTINUES TO STRUGGLE WITH SOME LOWER LUMBAR PAIN, PARTICULARLY IN THE PARAVERTEBRAL MUSCULATURE. HE HAS SOME MILD RADIATION INTO HIS BUTTOCK AREAS, BUT THE PAIN IS MARKEDLY IMPROVED COMPARED TO PREOPERATIVELY.¿ ON (B)(6) 2007 ¿ ¿HIS BACK PAIN HAS MARKEDLY IMPROVED AS WELL AS HIS LOWER EXTREMITY PAIN.¿ ¿HE DOES NOTE THAT HE HAS INTERMITTENT SPASMS AND PAIN INVOLVING HIS PARAVERTEBRAL MUSCULATURE.¿ ON (B)(6) 2007 ¿ CERVICAL MRI SHOWS ¿MULTIPLE CENTRAL AND BROAD-BASED CERVICAL DISC HERNIATIONS ARE PRESENT. MILD SPINAL STENOSIS AT C3-4, C4-5, C5-'6, C6-7 AND T1-T2 ARE PRESENT.¿ ON (B)(6) 2007 ¿ PT BEGAN A SERIES OF THREE CERVICAL EPIDURAL STEROID INJECTIONS. ON (B)(6) 2008 ¿ PT PRESENTS FOR FOLLOW-UP ¿COMPLAINING OF SIGNIFICANT LOW BACK PAIN.¿ ¿HE¿S NOT HAVING ANY RADICULAR SYMPTOMS.¿ ON (B)(6) 2008 ¿ LUMBAR X-RAYS SHOW ¿SOLID APPEARING FUSION OF THE LOWER LUMBAR SPINE IS NOTED. ADVANCED DEGENERATIVE DISC DISEASE AND FACET ARTHROSIS LUMBAR SPINE IS PRESENT.¿ ON (B)(6) 2008 ¿ PT PRESENTS TO PHYSICAL THERAPY EVALUATION. PT ¿STATES THAT HE STRUGGLES WITH CONSTANT BACK PAIN THAT WORSENS WITH WALKING. HE STATES THAT THE PAIN AND NUMBNESS SPREADS TO THE OUTSIDE OF HIS HIPS.¿ ON (B)(6) 2008 - PT. UNDERWENT PROCEDURE FOR LUMBAR EPIDURAL STEROID INJECTION. ON (B)(6) 2008 ¿ PT. UNDERWENT PROCEDURE FOR LUMBAR EPIDURAL STEROID INJECTION. ON (B)(6) 2009 - PT. UNDERWENT PROCEDURE FOR LUMBAR EPIDURAL STEROID INJECTION. ON (B)(6) 2009 - PT. UNDERWENT PROCEDURE FOR LUMBAR EPIDURAL STEROID INJECTION. ON (B)(6) 2009 - PT. UNDERWENT PROCEDURE FOR CERVICAL EPIDURAL STEROID INJECTION. ON (B)(6) 2010 ¿ PT. PRESENTS FOR VISIT WITH CHRONIC LOW BACK PAIN AND DEGENERATION OF CERVICAL DISC. ON (B)(6) 2010 - PT. UNDERWENT PROCEDURE FOR CERVICAL EPIDURAL STEROID INJECTION. ON (B)(6) 2012 ¿ PT. PRESENTS FOR VISIT WITH CHRONIC LOW BACK PAIN AND DEGENERATION OF CERVICAL DISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135073 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M115006AAF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R