BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2801848 · Received October 23, 2012

    Report

    Report Number
    1030489-2012-01934
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    December 7, 2015
    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): 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

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A LONG HISTORY OF LOWER BACK PAIN AND FAILURE OF ALL OTHER CONSERVATIVE THERAPY. THE PATIENT UNDERWENT A PROCEDURE FOR L5 LAMINECTOMY, BILATERAL FORAMINOTOMIES OF S1 NERVE ROOTS FOR STENOSIS, POSTERIOR LUMBAR INTERBODY FUSION L5-S1 WITH PEEK CAGES AND RHBMP-2/ACS, POSTEROLATERAL ARTHRODESIS L5-S1 WITH AUTOGRAFT AND RHBMP-2/ACS, AND POSTERIOR NON-SEGMENTAL INSTRUMENTATION L5-S1. THE PATIENT REPORTEDLY DID WELL DURING THE HOSPITAL COURSE POST-OPERATIVELY. ALLEGEDLY, POSTOPERATIVELY, THE PATIENT HAS DEVELOPED INTENSE PAIN, IMMOBILITY AND DISCOMFORT.

    Description of Event or Problem · 1

    PER MEDICAL RECORDS IT WAS REPORTED THAT ON (B)(6) 2005 THE PATIENT PRESENTED WITH COMPLAINT OF LOW BACK PAIN. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: 1. L5 LAMINECTOMY. 2. BILATERAL FORAMINOTOMIES OF S1 NERVE ROOTS FOR STENOSIS. 3. POSTERIOR LUMBAR INTERBODY FUSION USING PEEK CAGES AND RHBMP-2. 4. ARTHRODESIS, LUMBAR, L5-S1 POSTEROLATERALLY. 5 POSTERIOR NON-SEGMENTAL INSTRUMENTATION L5-S1. 6. USE OF FRAMELESS COMPUTER ASSISTED STEREOTAXIS OR FLUORONAVIGATION. 7. INTRAOPERATIVE EMG EVALUATION OF THE L5 AND S1 NERVE ROOTS. 8. PEDICLE STIMULATION, L5 AND S1 NERVE ROOTS. PER OP NOTES: THE ENDPLATE WAS PREPARED, AN 8X22 GRAFT WITH RHBMP-2 WAS THEN TAPPED INTO PLACE. INTRAOPERATIVE EMG EVALUATION WAS DONE THROUGHOUT THE CASE . THE DILATOR ON THE CONTRALATERAL SIDE WAS REMOVED AND ENDPLATE WAS PREPARED IN A SIMILAR MANNER AND 8X22 GRAFT WITH RHBMP-2 INTO ITS POSITION. THE GRAFT WAS A PEEK CAGE. PEDICLE SCREWS WERE PLACED INTO S1 AND L5. EACH SCREW WAS DONE WITH A TAP. AFTER THAT , DECORTICATED POSTEROLATERALLY, PLACED AUTOGRAFT SPINE, LOCAL AS WELL AS INFUSE AND THEN 5 CM RODS WERE PLACED BILATERALLY.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Required Intervention