BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4860999 · Received June 23, 2015

    Report

    Report Number
    1030489-2015-01258
    Event Type
    Injury
    Date Received
    June 23, 2015
    Report Date
    July 31, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR APPLICABLE MEDICAL RECORDS OR IMAGING STUDIES WERE RETURNED NOR PROVIDED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2013: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH C4 TO C7 CERVICAL STENOSIS AND CERVICAL RADICULOPATHY AND UNDERWENT THE FOLLOWING PROCEDURE: C4-5, C5-6, C6-7 ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH MACHINED ALLOGRAFT INTERBODY SPACERS AND ANTERIOR INSTRUMENTATION FROM C4 TO C7. AS PER OP-NOTES, ¿ AN 11MM LORDOTIC MACHINED ALLOGRAFT CORTICAL INTERBODY SPACER WAS THEN FILLED WITH 1/6TH OF THE SPONGE OF RHBMP-2/ ACS AND THEN IMPACTED INTO THE DISC SPACE ACHIEVING A GOOD FIT. THE EXACT SAME DECOMPRESSION, DISCECTOMY AND INTERBODY GRAFTING WAS THEN PERFORMED AT C5-6 AND C6-7 EXCEPT AT THESE TWO LEVELS THE IMPLANTS WERE 7 MM IN HEIGHT. ONCE THE INTERBODY GRAFTING AND DECOMPRESSIONS WERE COMPLETED AT ALL THREE LEVELS, A GLOBUS PROVIDENCE PLATE 20 NUN IN HEIGHT WAS SECURED WITH 16 NUN SCREWS, TWO AT EACH LEVEL FROM C4 TO C7. THE RETRACTORS WERE THEN REMOVED AND HEMOSTASIS WAS ACHIEVED.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE OBSERVED.

    Description of Event or Problem · 1

    PROCEDURE: ANTERIOR CERVICAL FUSION SURGERY LEVELS IMPLANTED: C4-C7 IT WAS REPORTED THAT, THE PATIENT UNDERWENT ANTERIOR CERVICAL FUSION SURGERY ON THE CERVICAL REGION AT LEVELS C4-C7. THE PATIENT WAS IMPLANTED WITH RHBMP-2 AND COLLAGEN SPONGE WHICH WAS APPLIED ON CERVICAL SPINE. THE RHBMP-2 AND COLLAGEN SPONGE WAS USED TO FUSE MORE THAN ONE LEVEL OF THE SPINE. POST-OP, THE PATIENT COMPLAINED OF INCREASINGLY SEVERE LOW NECK PAIN WITH RADICULOPATHY INTO HER UPPER EXTREMITIES. PATIENT STILL CONTINUES TO EXPERIENCE SEVERE AND UNRELENTING PAIN IN HER NECK WITH RADICULOPATHY INTO HER UPPER EXTREMITIES. SHE ALSO EXPERIENCES HEADACHES AND DIFFICULTY SPEAKING, BREATHING AND SWALLOWING. PATIENT INJURIES PREVENTED HER FROM PRACTICING DAILY LIFE ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405604 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111210AAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other