BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2884597 · Received December 23, 2012

    Report

    Report Number
    1030489-2012-02933
    Event Type
    Injury
    Date Received
    December 23, 2012
    Report Date
    May 23, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CERVICAL PLATE, LT CAGE (IMPLANT (B)(6) 2009). (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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)(4).

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEGENERATIVE DISC DISEASE WITH STENOSIS C5-6-7. THE PATIENT UNDERWENT AN ACDF C5-6-7 USING PEEK INTERBODY DEVICES, RHBMP-2/ACS AND ANTERIOR PLATING. THE RHBMP-2/ACS WAS PLACED WITHIN EACH INTERBODY DEVICE. THERE WERE NO NOTED COMPLICATIONS. THE PATIENT REPORTEDLY SUSTAINED UNSPECIFIED INJURIES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6)-2009, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY, THE BILATERAL FORAMINOTOMY OF NERVE ROOTS AND DURAL SAC WITH ARTHRODESIS USING PEEK CAGES, RHBMP-2/ACS, AND ANTERIOR PLATING C5, C6, C7. THE PATIENT RETURNED HOME BUT HER PAIN AND DIFFICULTIES DID NOT SUBSIDE. THE PATIENT NOW SUFFERS FROM CHRONIC PAIN SYNDROME, BACK AND NECK PAIN, DESICCATED SPINAL DISCS, CARDIOVASCULAR INJURIES, LIVER DAMAGE, UNWANTED BONE GROWTH, CYST FORMATION, HERNIATED BULGING DISCS, MUSCLOSKELETAL INJURIES, DETERIORATION OF THE SPINE, ANXIETY, AND NARCOTIC DEPENDENCE FROM PRESCRIBED PAIN KILLERS. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY, THE BILATERAL FORAMINOTOMY OF NERVE ROOTS AND DURAL SAC WITH ARTHRODESIS USING CERVICAL PLATING AND RHBMP-2/ACS, FUSING C5, C6, AND C7.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2009: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: DEGENERATIVE DISK DISEASE WITH STENOSIS C6-C7, C5-C6. PROCEDURE: ANTERIOR CERVICAL DISCECTOMY. BILATERAL FORAMINOTOMY WITH DECOMPRESSION OF NERVE ROOTS AND DURAL SAC WITH ARTHRODESIS USING PEEK CAGES/RHBMP-2/ACS. PLATING C5, C6 AND C7. PREOPERATIVE AND INTRAOPERATIVE NEUROMETRIC MONITORING. PER-OP NOTES: DISTRACTION WAS CARRIED OUT TO C5-C6 FIRST. THERE WAS AN ELEMENT OF DISC HERNIATION, SPURRING POSTERIORLY AND THIS WAS COMPRESSING THE DURAL SAC. A PEEK CAGE 6MM WAS CHOSEN AND FILLED WITH RHBMP-2, PUT INTO POSITION. SURGEON THEN WENT BACK TO C4-C5, DISCECTOMY WAS CARRIED OUT. SIMILAR PROCEDURE CARRIED OUT AND A PEEK CAGE WAS INSERTED WITH RHBMP-2 AND PLACED. PLATING WAS THEN USED. A CAGE TAPPED IN POSITION WITH SCREWS.

    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 Other