BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2830052 · Received November 13, 2012

    Report

    Report Number
    1030489-2012-02108
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    December 1, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 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 ALLEGEDLY SUSTAINED UNSPECIFIED INJURIES RESULTING FROM A UNSPECIFIED SURGICAL PROCEDURE USING RHBM P-2/ACS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY ON (B)(6) 2010, SELECT PARTS OF RHBMP-2/ACS (I.E. ONLY THE RHBMP-2 AND COLLAGEN SPONGE) WERE USED IN THE PATIENT FROM A POSTERIOR APPROACH. IT WAS ALSO REPORTED THAT THE RHBMP-2 COLLAGEN SPONGE WAS PLACED OUTSIDE A CAGE (I.E. IN THE DISC SPACE). REPORTEDLY, THE PATIENT'S POST-OPERATIVE PERIOD HAD BEEN MARKED BY A PERIOD OF IMPROVEMENT, FOLLOWED BY INCREASINGLY SEVERE AND CHRONIC LOW BACK PAIN, RADIATING PAIN INTO HIS LOWER EXTREMITIES, MID BACK PAIN, RIGHT HIP PAIN, AND DIFFICULTY STANDING AND WALKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2010: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED RECURRENT STENOSIS RIGHT L5-S1 WITH COLLAPSE AT L5-S1 AND UNDERWENT THE FOLLOWING PROCEDURE: REVISION DECOMPRESSION L5-S1 WITH COMPLETE FACETECTOMY AND A RIGHT L5-S1 FUSION WITH PEDICLE SCREW INSTRUMENTATION AND INTERBODY FUSION DEVICE. AS PER THE OPERATIVE NOTES: ¿ROTATING CUTTERS WERE USED, CURETTE WAS USED AND THE DISC WAS PREPARED FOR FUSION, TRIAL-10 WAS PLACED. PEDICLE SCREWS WERE THEN PLACED ON THE LEFT SIDE USING ANATOMICAL LOCALIZATION AT L5-S1 WITH NEURO MONITORING CARRIED OUT AS WELL, AS WELL AS RHBMP-2/ACS WAS USED ALONG WITH ON-Q. THE TRIAL WAS REMOVED ON THE RIGHT SIDE AND THE REAL 10 X 22 CAGE WAS PACKED WITH RHBMP-2/ACS. THE ANTERIOR PART OF THE DISC SPACE WAS PACKED WITH RHBMP-2/ACS AND THEN THE DECOMPRESSION ONE WAS PACKED IN BEHIND THAT.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS.

    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 M110806AAK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other