BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3140930 · Received June 3, 2013

    Report

    Report Number
    1030489-2013-02048
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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

    (B)(6) 2006 ¿ PT PRESENTED TO SURGERY WITH STENOSIS WITH INSTABILITY LEADING TO CHRONIC LOW BACK PAIN AND LUMBAR RADICULAR PAIN. PROCEDURE WAS FOR REMOVAL OF POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION. EXPLORATION OF SPINAL FUSION. REDO POSTERIOR LUMBAR FUSION/FIXATION. L3 LAMINECTOMY. BILATERAL L3-L4 FORAMINOTOMIES. POSTERIOR ARTHRODESIS USING BMP AND MASTERGRAFT GRANULES AS WELL AS AUTOLOGOUS BONE GRAFT. BMP WAS PLACED IN THE LATERAL GUTTERS PACKED WITH MASTERGRAFT GRANULES, THEN SUPPLEMENTED WITH AUTOGRAFT BONE. (B)(6) 2006 ¿ PT PRESENTED TO SURGERY WITH RIGHT L5 RADICULOPATHY WITH MOTOR WEAKNESS OF THE RIGHT FOOT. PRE-OPERATIVE CT SCAN WAS TAKEN ¿THAT APPEARED TO SHOW THE L5 PEDICLE SCREW WITHIN THE SPINAL CANAL; HOWEVER, THIS WAS NOT CONFIRMED DURING THE OPERATIVE PROCEDURE, AND, INSTEAD, DURING PROBING OF THE PEDICLE, NO BONY BREACH WAS PALPABLE OR DISCOVERED.¿ PROCEDURE PERFORMED WAS ¿EXPOSURE OF A PREVIOUS RIGHT FUSION/INSTRUMENTATION SITE WITH REMOVAL OF THE L5 PEDICLE SCREW. REPLACEMENT OF THE L3-L4 ROD AND FUSION OF THE L3-L4 AREA. REINFORCEMENT OF A BONY FUSION/POSTERIOR ARTHRODESIS FROM L3 TO L4 USING BMP (BONE MORPHOGENIC PROTEIN) AS WELL AS MASTERGRAFT.¿ ¿UPON INSPECTION, THE PROBING CERTAINLY DID NOT APPEAR TO REVEAL BONY BREACH. IN FACT, ALL WALLS OF THE PEDICLE SCREW HOLE APPEARED TO BE COMPLETELY SURROUNDED BY BONE, AND NO EVIDENCE OF BREACH WAS OBSERVED. THE CT SCAN WAS THEN RE-EVALUATED, AND, AGAIN, THE PREOPERATIVE CT SCAN SHOWED THE L5 PEDICLE SCREW IN THE CANAL; THAT MAY HAVE BEEN CONTRIBUTING TO THE PATIENT'S PRE-OPERATIVE SYMPTOMS OF A RIGHT L5 RADICULOPATHY AND, THEREFORE, BECAUSE OF THE PATIENT'S CLINICAL SYMPTOMATOLOGY, THE L5 PEDICLE SCREW WAS REMOVED AND NOT REPLACED.¿ ¿THE PREVIOUS BMP AND MASTERGRAFT GRANULES APPEARED TO BE WELLIN PLACE. THESE AREAS WERE REINFORCED WITH NEW BMP WITH MASTERGRAFT GRANULES AND PARTICULARLY REINFORCED AT THE L4-L5 AND L5-S1 LEVELS.¿ (B)(6) 2007 ¿ PT. PRESENTS FOR SURGERY WITH COMPLAINTS OF BACK PAIN WITH BILATERAL KNEE PAIN. ¿PATIENT NOTES THE ONSET OF SYMPTOMS AFTER MOVING IN HER SEAT AND SUDDENLY HAVING LOW BACK PAIN.¿ PT. UNDERWENT PROCEDURE FOR ANTERIOR INTERBODY FUSION L2-L3 ANDL3-L4 USING COUGAR CAGES AND BMP, AND REMOVAL OF POSTERIOR LUMBAR HARDWARE, REPLACEMENT WITH XSTOP, L2 TO L4, AND FUSION USING BMP.BMP WAS PLACED INSIDE THE INTERBODY CAGES AND ROLLED OVER MASTERGRAFT AND PLACED INTO THE LATERAL GUTTERS. (B)(6) 2012 ¿ PT. PRESENTS FOR FOLLOW-UP WITH ¿LOW BACK AND CHRONIC LOWER EXTREMITY PAIN AND NUMBNESS SECONDARY TO LUMBAR SPINAL STENOSIS.¿ (B)(6) 2012 ¿ PT. PRESENTS FOR FOLLOW-UP WITH ¿PERSISTENT UPPER, MID AND LOW BACK PAIN SECONDARY TO LUMBAR SPINAL STENOSIS.¿ (B)(6) 2013 ¿ PT PRESENTS FOR FOLLOW-UP WITH CHRONIC BACK PAIN AND SPINAL STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244062 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110607AAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention