BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2884700 · Received December 24, 2012

    Report

    Report Number
    1030489-2012-02935
    Event Type
    Injury
    Date Received
    December 24, 2012
    Date of Event
    January 21, 2010
    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

    (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 UNDERWENT ANTERIOR INTERBODY FUSION AT L5-S1 USING ALLOGRAFT, AUTOGRAFT, AND ANTERIOR BULLET TIP CAGES PACKED WITH RHBMP-2/ACS AND POSTERIOR LATERAL FUSION AT L5/S1 USING PIONEER POSTERIOR INSTRUMENTATION. THE PATIENT WAS TRANSPORTED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO NOTED COMPLICATIONS. ON POD 1 THE PATIENT REPORTED BACK PAIN. THE SURGEON NOTED THAT THE BACK WOUND HAD A SMALL AMOUNT OF SERO-SANGUINOUS DRAINAGE. PATIENT REPORTED A DECREASE IN LEG SYMPTOMS AND A DECREASE IN CALF PAIN. VITAL SIGNS WERE STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT AND ANTERIOR CERVICAL DISCECTOMY AT C7 AND ARTHRODESIS AT C6-7, ANTERIOR CERVICAL PLATING C6-7, CAGE INSERTION, AND ALLOGRAFTING. ON (B)(6) 2010, THE PATIENT UNDERWENT A DECOMPRESSION LAMINECTOMY AT L5, ANTERIOR DISCECTOMY OF L5-S1 FROM THE POSTERIOR SIDE, ANTERIOR INTERBODY FUSION L5-S1 USING ALLOGRAFT, AUTOGRAFT, AND RHBMP-2/ACS, POSTERIOR LATERAL FUSION AND INSTRUMENTATION AT L5-S1. THE PATIENT NOW SUFFERS FROM NECK/BACK/CHEST PAIN, HEADACHE, HERNIATED BULGING DISCS, AND UNWANTED BONE GROWTH. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2010: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: DISCOGENIC LOW BACK PAIN L5-S1. DEGENERATIVE DISC DISEASE L5-S1. HERNIATED NUCLEUS POLYPOSIS (RIGHT) L5-S1. POSITIVE DISKOGRAM AT L5-S1. PATIENT UNDERWENT FOLLOWING PROCEDURES: DECOMPRESSION LAMINECTOMY L5. ANTERIOR DISCECTOMY OF L5-S1 FROM THE POSTERIOR SIDE. ANTERIOR INTERBODY FUSION L5-S1 USING ALLOGRAFT, AUTOGRAFT AND RHBMP-2. ANTERIOR CAGE INSERTION OF 10MM CAGES X2. POSTERIOR LATERAL FUSION L5-S1. POSTERIOR LATERAL INSTRUMENTATION L5-S1 USING A PIONEER SPINE WITH FOUR 40 MM PEDICLE SCREWS AND TWO 50MM RODS. PER OP-NOTES- "THE THORACOLUMBAR FASCIA WAS SPLIT IN LINE WITH THE SPINE. THE PARASPINAL MUSCULATURE WAS ELEVATED OFF OF THE SPINE ON BOTH SIDES OUT TO THE LEVEL OF THE FACET POINTS... A CROSS-TABLE LATERAL X-RAY WAS TAKEN TO OBTAIN TO IDENTIFY THE L5-S1 INTERSPACE. AT THAT POINT, THE DISSECTION WAS THEN CARRIED OUT TO THE LEVEL OF THE TRANSVERSE PROCESSES AND SACRAL ALA. CEREBELLER RETRACTORS WERE PLACED IN TO RETRACT SOFT TISSUES. .. THEN USING THE SHAVERS FROM THE POSTERIOR TO ANTERIOR APPROACH, THE DISK SPACE WE SHAVED UP TO A SIZE 10 SHAVER ON BOTH SIDES. PITUATARY RONGEUR WAS USED TO REMOVE THE DISK MATERIAL. THE END-PLATES WERE CURETTED AND IT WAS FOUND THAT ALL DISK MATERIAL WAS REMOVED. AFTER THAT WAS COMPLETED, 10MM SIZER WAS PLACED. RHBMP-2 WAS OPENED UP ON THE BACK TABLE. VITOSS WAS ALSO OPENED AND BLOOD WAS MIXED WITH THE VITOSS. THEN SOME VITOSS WAS PLACED INSIDE THE ANTERIOR ASPECT OF THE L5-S1 DISK SPACE. CAGE WAS THEN PLACED. RHBMP-2 WAS PACKED INSIDE THE CAGES. THIS ENTIRE PROCEDURE WAS DONE UNDER C-ARM VISUALIZATION CHECKING TO MAKE SURE THE CAGES WERE IN GOOD POSITION AND THE SHAVERS WERE IN GOOD POSITION.

    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 M110802AAJ

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Other