BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2990144 · Received March 5, 2013

    Report

    Report Number
    1030489-2013-00669
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    March 9, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGERY USING RHBMP-2/ACS. POST-OP, THE PATIENT REPORTEDLY DEVELOPED "PROBLEMS SUCH AS PAIN, REQUIRED ME TO NEED ANOTHER SURGERY, PHYSICAL LIMITATIONS, AS WELL AS MENTAL ANGUISH."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED AND WAS PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: L4-L5 SPONDYLOLISTHESIS. PRE-OPERATIVELY, IMAGING STUDIES DEMONSTRATE SEVERE LUMBAR DISK DEGENERATION WITH EVIDENCE OF INSTABILITY AND NERVE WITH IMPINGEMENT. SHE UNDERWENT THE FOLLOWING PROCEDURES: L4 DECOMPRESSIVE LAMINECTOMY. L5 DECOMPRESSIVE LAMINECTOMY. L4-L5 POSTERIOR ANTIBODY FUSION. POSTEROLATERAL ARTHRODESIS L4-L5. PEDICLE SCREW FIXATION 6.5X40MM SCREWS L4-L5. MICRODISSECTION. INTRAOPERATIVE FLUOROSCOPY. APPLICATION OF EPIDURAL NEUROANESTHETIC AGENT- MARCAINE. APPLICATION OF INTRATHECAL NEUROANESTHETIC AGENT- DURAMORPH. MORCELLIZED ALLOGRAFT. MORCELLIZED AUTOGRAFT. APPLICATION OF INTRAVERTEBRAL DEVICE L4-L5. AS PER THE OPERATIVE NOTES, ¿SIZERS WERE INSERTED INTO THE DISK SPACE AND WAS SELECTED UNTIL THE APPROPRIATE SIZE WAS SELECTED AND FILLED WITH BONE MORPHOGENIC PROTEIN INFUSED. THIS WAS INSERTED INTO THE DISKECTOMY DEFECT. AT THIS POINT THE QUADRANT RETRACTOR WAS REMOVED AND THE AP SINGLE FLUOROSCOPY WAS BOUGHT INTO THE CASE.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. SHE WAS DISCHARGED ON (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94358 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110705AAK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention