BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5030828 · Received August 26, 2015

    Report

    Report Number
    1030489-2015-02094
    Event Type
    Injury
    Date Received
    August 26, 2015
    Report Date
    July 27, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) 2002: THE PATIENT UNDERWENT X RAY OF CHEST FOR PRE-SURGERY TESTING DUE TO LUMBAR HNP, PA <(>&<)> LATERAL VIEWS. IMPRESSION: NO ACUTE CARDIOPULMONARY DISEASE. ON (B)(6) 2002: THE PATIENT PRESENTED WITH PAIN LOCATED ON RIGHT SIDE OF BACK AND RADIATES DOWN RIGHT IEG WITH NUMBNESS. THE PATIENT HAD FOLLOWING PREOPERATIVE DIAGNOSIS: SEVERELY PAINFUL DEGENERATIVE DISK DISEASE, L5/S1. RECURRENT HERNIATED NUCLEUS PULPOSUS, L5/S1. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: LAPAROSCOPIC ANTERIOR EXPOSURE, RETROPERITONEAL EXPOSURE OF THE L5/S1 JUNCTION WITH MOBILIZATION OF THE LEFT AND RIGHT ILIAC ARTERY AND VEINS. LAPAROSCOPIC ANTERIOR DISKECTOMY OF RECURRENT HERNIATED NUCLEUS PULPOSUS, L5/S1. LAPAROSCOPIC ANTERIOR INTERBODY FUSION, L5/S1, WITH BMP. LAPAROSCOPIC PLACEMENT OF TITANIUM CAGE, LEFT SIDE, L5/S1. LAPAROSCOPIC PLACEMENT OF TITANIUM CAGE, RIGHT SIDE, L5/S1. INTRAOPERATIVE FLUOROSCOPY AND INTERPRETATION. PER OP-NOTE, THE DISK SPACE WAS THEN DRILLED AND AN CAGE OF THE APPROPRIATE SIZE WAS PARTIALLY PLACED MID POSITION. IT WAS NOT COUNT ERSUNK IN ORDER NOT TO DISTRACT THE DISK SPACE. THE TANG RETRACTOR WAS THEN REMOVED AND THEN REPLACED ON THE RIGHT SIDE. THE DISTRACTOR PLUG WAS THEN REMOVED. THE RIGHT SIDE OF THE DISK SPACE WAS THEN DRILLED. THE DRILL WAS REMOVED AND A CAGE WAS THEN INSERTED AND COUNTERSUNK COMPLETELY 6 MM ON THE RIGHT SIDE. C-ARM FLUOROSCOPY WAS THEN PREVIOUSLY USED TO DOCUMENT AND MARK THE MIDLINE. IT WAS THEN USED TO DOCUMENT ADEQUATE POSTERIOR PLACEMENT OF THE CAGE. THIS WAS CONFIRMED. THE LEFT CAGE WAS THEN COUNTERSUNK FURTHER UNTIL A LEVEL WITH THE RIGHT HAND CAGE. THE BMP SPONGES WERE CONFIRMED TO BE INTACT. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE. RESULT: INTERBODY FUSION CAGES ARE IN POSITION AT L5-S1. THE STATURE AND ALIGNMENT OF THE VERTEBRAL BODIES IS WELL MAINTAINED. IMPRESSION: STATUS-POST L5-S1 FUSION. ON (B)(6) 2003: THE PATIENT PRESENTED WITH NUMBNESS AND TINGLING IN BOTH LEGS, PAIN ON BOTH SIDES, RIGHT MORE THAN LEFT. THE PATIENT PRESENTED WITH FOLLOWING PREOPERATIVE DIAGNOSIS: POSSIBLE DISCOGENIC PAIN. THE PATIENT UNDERWENT FOLLOWING PROCEDURES: DISKOGRAM, T12-L 1. DISKOGRAM, L 1-L2. DISKOGRAM, L2-L3. DISKOGRAM, L3-L4. DISKOGRAM, L4-L5. PROVOCATIVE SALINE ACCEPTANCE TEST AT T12-L 1. PROVOCATIVE SALINE ACCEPTANCE TEST AT L 1-L2. PROVOCATIVE SALINE ACCEPTANCE TEST AT L2-L3. PROVOCATIVE SALINE ACCEPTANCE TEST AT L3-L4. PROVOCATIVE SALINE ACCEPTANCE TEST AT L4-L5. LNTRAOPERATIVE FLUOROSCOPY INTERPRETATION. THE PATIENT HAD FOLLOWING POSTOPERATIVE DIAGNOSIS: SOME DEGREE OF DIFFUSE DISCOGENIC PAIN, MOST ACUTE AT L2-3. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE PATIENT UNDERWENT PORTABLE INTRAOPERATIVE AP WITH LATERAL LUMBAR SPINE X-RAYS DURING MULTILEVEL INTRAOPERATIVE DISCOGRAM PROCEDURE. IMPRESSION: MULTILEVEL LUMBAR DISCOGRAM STUDY PERFORMED APPARENTLY AT THE T12-L 1 THROUGH L4-5 LEVELS. ON (B)(6) 2005: THE PATIENT UNDERWENT MRI OF LUMBAR SPINE WITH AND WITHOUT CONTRAST DUE TO BACK PAIN RADIATING TO BOTH LEGS, HISTORY OF PRIOR SURGERY. IMPRESSION: PRIOR INTERBODY FUSION AT THE L2-3 AND L5-S1 LEVELS. CONGENITALLY SHORT PEDICLES WITH RELATIVELY NARROW SPINAL CANAL AND MILD SPINAL STENOSIS AT L2-3 AND L3-4. NO EVIDENCE OF DISK HERNIATION. MILD CHRONIC DEGENERATIVE CHANGES OF THE APOPHYSEAL JOINTS THROUGHOUT THE LUMBAR SPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564751 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA MA111004D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other