BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2884679 · Received December 24, 2012

    Report

    Report Number
    1030489-2012-02934
    Event Type
    Injury
    Date Received
    December 24, 2012
    Report Date
    May 16, 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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SEVERE INCREASING NECK PAIN WHICH DID NOT RESPOND TO CONSERVATIVE TREATMENT INCLUDING INJECTIONS AND PAIN MANAGEMENT. THE PATIENT WAS DIAGNOSED WITH CERVICALGIA WITH FIBROUS NONUNION OF A PREVIOUS C5-6 FUSION WITH HARDWARE FAILURE AND MARGINAL CERVICAL STENOSIS. THE PATIENT UNDERWENT A REVISION C5-6 ANTERIOR CERVICAL CORPECTOMY AND FUSION USING SPINAL USA PEEK CAGE AND ANTERIOR PLATE WITH RHBMP-2/ACS. THERE WERE NO NOTED COMPLICATIONS. POST-OPERATIVELY, THE PATIENT ALLEGEDLY SUSTAINED UNSPECIFIED INJURIES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION AT C5-6, THE INSERTION OF A SPINAL USA PEEK CAGE AT C5-6 FILLED WITH ONE-THIRD OF ONE STRIP OF RHBMP-2/ACS, THE ANTERIOR CERVICAL HARDWARE REMOVAL, AND THE ANTERIOR CERVICAL AT C5-6 USING SPINAL USA PLATE WITH SCREWS ON (B)(6) 2010. POSTOPERATIVELY, PATIENT NOW SUFFERS FROM INJURIES INCLUDING CHRONIC PAIN SYNDROME, NECK PAIN, UNWANTED BONE GROWTH, CYST FORMATION, HERNIA, OBSTRUCTION OF AIRWAY, ANXIETY, AND NARCOTIC DEPENDENCE FROM PRESCRIBED PAINKILLERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION AT C5-6, THE INSERTION OF A SPINAL USA PEEK CAGE AT C5-6 FILLED WITH RHBMP-2/ACS. POST-OP, THE PATIENT DEVELOPED CHRONIC PAIN SYNDROME, NECK PAIN, UNWANTED BONE GROWTH, CYST FORMATION, HERNIA, OBSTRUCTION OF AIRWAY, ANXIETY, AND NARCOTIC DEPENDENCE FROM PRESCRIBED PAINKILLERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2010: PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSIS OF CERVICALGIA WITH NON UNION OF PREVIOUS CERVICAL FUSION WITH HARDWARE FAILURE AND MARGINAL CERVICAL STENOSIS AND UNDERWENT ANTERIOR CERVICAL FUSION ,C5-6;CORPECTOMY, ANTERIOR CERVICAL C5-6 WITH TAKEDOWN OF FIBROUS NON UNION, MICROSCOPIC; INSERTION OF A 10 MM PEEK CAGE, C5-6 FILLED WITH ONE THIRD OF ONE STRIP OF RHBMP-2/ACS; ANTERIOR CERVICAL HARDWARE REMOVAL, C5-6; ANTERIOR CERVICAL PLATING, C5-6 USING PLATE WITH 16 MM SCREWS. PER OPERATIVE REPORT ¿¿TRIAL SPACING WAS PERFORMED AND A 10 MM SPACER WAS SELECTED. WE PREPARED A SMALL RHBMP-2/ACS KIT. I USED ONE THIRD OF ONE STRIP OF RHBMP-2/ACS AND USED IT TO PACK THE CAGE AND THEN THE CAGE WAS INSERTED WITH SLIGHTLY COUNTERSUNK. I MADE CERTAIN THAT NONE OF THE RHBMP-2/ACS WAS EXPOSED TO SOFT TISSUE. DISTRACTOR WAS RELEASED. THE CASPAR PINS WERE REMOVED AND A CERVICAL PLATE WAS SELECTED. I PLACED THIS PLATE SOMEWHAT LEFT OF MIDLINE SO AS TO NOT INTERFERE WITH THE RESIDUAL SCREW FRAGMENT IN THE RIGHT SIDE OF L5. I DRILLED NEW HOLES USING 16 X 4 MM SCREWS AT C6 AND ON THE RIGHT AT C5 AND A 4.5 MM SCREWS ON THE LEFT AT C5 WHERE THERE WAS SOME OVERLAP OF PREVIOUS SCREW HOLE. EXCELLENT PURCHASE WITH ALL SCREWS AND WAS ACHIEVED AND I ENGAGED A LOCKING RIVETS. THE SCREWS ARE IN GOOD POSITION.¿ NO PATIENT COMPLICATIONS WERE IDENTIFIED. FINDINGS: CONSISTENT WITH PREOPERATIVE X-RAYS AND CT SCAN WITH FIBROUS NON UNION, INTERSPERSED CORTICAL BONE AND FIBROTIC TISSUE WITH MOTION EVIDENT WITH DISTRACTION AND RELEASE OF DISTRACTION AT THE NON UNION SITE.

    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