BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3052430 · Received April 11, 2013

    Report

    Report Number
    1030489-2013-01000
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    April 14, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING RHBMP-2/ACS. POST-OP, THE PATIENT REPORTEDLY HAS HAD TO VISIT THE DOCTOR FREQUENTLY, HAS HAD COMPLICATIONS, PAIN, AND HAS UNDERGONE A REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ALIF PROCEDURE FROM L3 TO L5, USING RHBMP-2/ACS IN THE SURGERY. SOMETIME POSTOP, THE PATIENT REPORTEDLY EXPERIENCED DYSTROPHIC BONE CAUSING CENTRAL CANAL AND BILATERAL FORAMINAL STENOSIS THAT IMPINGES ON THE SPINAL CORD AND EXITING NERVE ROOTS. THE PATIENT HAS UNRELENTING PAIN THAT RADIATES INTO HIS LOWER EXTREMITIES. HE HAS ALSO HAD A SPINAL CORD STIMULATOR IMPLANTED ON (B)(6) 2012 AS A PALLIATIVE MEASURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012 THE PATIENT UNDERWENT CT SCAN OF THE CHEST FROM THORACIC INLET THROUGH THE ADRENAL GLANDS. IMPRESSIONS: DEPENDENT BIBASAL ATELECTASIS/AIRSPACE DISEASE WITH MILD PLEURAL REACTION. ADDITIONAL RIGHT UPPER LOBE AIRSPACE DISEASE AND RIGHT GREATER THAN LEFT UPPER LOBE EMPHYSEMA CHANGE. PUNCTUATE CALCIFIED GRANULOMAS, LEFT LOWER LOBE, LEFT HELIUM AND POSTERIOR MEDIASTINUM. THE PATIENT ALSO UNDERWENT CT SCAN OF THE BRAIN/HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009 PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: ABDOMINAL PAIN GASTRITIS. ON (B)(6) 2011: PATIENT UNDERWENT X-RAY OF LUMBAR SPINE. PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: "BLE" PAIN AND SWELLING POST SURGERY. ON (B)(6) 2011 PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: PELVIC PAIN. ON (B)(6) 2012: PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: CERVICAL SPONDYLOSIS, LOWER EXTREMITY WEAKNESS. ON (B)(6) 2012 PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: PAIN AND STIFFNESS RIGHT WRIST. ON (B)(6) 2013 PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: LUMBOSACRAL SPONDYLOSIS. ON (B)(6) 2013 PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: ABDOMINAL PAIN. ON (B)(6) 2014 PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: DEGENERATION OF CERVICAL INTERVERTEBRAL. ON (B)(6) 2015 PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: LUMBAR SPONDYLOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT WAS DIAGNOSED WITH LUMBOSACRAL SPONDYLOSIS. THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE DUE TO LOW BACK PAIN. FINDINGS: AT THE L2-L43 , THERE IS CONTRAST PRESENT WITHIN THE CENTRAL PORTION OF THE INTERVERTEBRAL DISC WITH A SMALL AMOUNT OF CONTRAST EXTENDING FAR LATERALLY AND TO THE LEFT TO THE MARGINS OF THE END PLATES. AT THE L3-4 LEVEL, THERE WAS CONTRAST PRESENT DIFFUSELY THROUGHOUT THE INTERVERTEBRAL DISC AND CONTRAST EXTENDS TO AND BEYOND THE MARGINAL CONFINES OF THE END PLATES. NO FOCAL CONTRAST EXTENDING BEYOND THE CONFINES OF THE ENDPLATES IS EVIDENT. AT THE L4-5 LEVEL, THERE IS CONTRAST PRESENT DIFFUSELY WITH CONTRAST EXTENDING TO THE MARGINS AND BEYOND THE MARGINS OF THE END PLATES. NO DEFINITIVE FOCUS OF CONTRAST EXTENDS BEYOND THE MARGINS OF THE END PLATES. ON (B)(6) 2012 THE PATIENT PRESENTED FOR AN OFFICE VISIT. THE PATIENT WAS DIAGNOSED WITH LUMBAR SPONDYLOSIS. THE PATIENT UNDERWENT X-RAY OF THE CHEST PA AND LATERAL. NO ACUTE INFILTRATE OR PLEURAL EFFUSIONS ARE IDENTIFIED. THE SIZE OF THE CARDIAC SILHOUETTE APPEARS WITHIN NORMAL LIMITS. POST OPERATIVE CHANGES ARE EVIDENT. NO ACUTE CARDIOPULMONARY PROCESS IS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON, (B)(6) 2014 THE PATIENT UNDERWENT RAD CHEST PA <(>&<)> LATERAL. ON (B)(6) 2015 PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO TOOTHACHE. ON (B)(6) 2015 PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO DYSPNEA, RASH. ON (B)(6) 2015 PER BILLING RECORDS, PATIENT UNDERWENT CHEST X-RAY. ON (B)(6) 2015 PATIENT UNDERWENT CT HEAD WITHOUT CONTRAST.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE PATIENT PRESENTED WITH BLE PAIN AND SWELLING POST-SURGERY AS ADMITTING DIAGNOSIS. THE PATIENT UNDERWENT DPUS DUPLEX VENOUS EXT BIL. IMPRESSION: NORMAL VENOUS ULTRASOUND OF THE LOWER EXTREMITIES. ON (B)(6) 2011: PATIENT UNDERWENT X-RAY OF LUMBAR SPINE. ON (B)(6) 2011: THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE AP AND LATERAL. IMPRESSION: STABLE LOWER LUMBAR FUSION. ON (B)(6) 2011: IMPRESSION: POST-OP CHANGES AS DESCRIBED ABOVE; LIMITED EVALUATION OF SPONDYLOSIS DUE TO METALLIC HARDWARE. ON (B)(6) 2011: IMPRESSION: STABLE POSTOPERATIVE CHANGES OF CERVICAL SPINE WITH MILD STRAIGHTENING AND SPONDYLOSIS. STABLE POSITION OF SUBOCCIPITAL NEURAL STIMULATOR WIRES. ON (B)(6) 2011: THE PATIENT UNDERWENT X-RAY MYELOGRAM LUMBAR. IMPRESSION: NO SIGNIFICANT ABNORMALITY. ON (B)(6) 2012 THE PATIENT UNDERWENT X-RAY OF CHEST PA LATERAL PRE-OP. IMPRESSION: NO ACTIVE PULMONARY DISEASE, NO DETRIMENTAL CHANGE. ON (B)(6) 2012 THE PATIENT PRESENTED FOR MEDICAL EVALUATION FOR MANAGEMENT. ASSESSMENT: BACK PAIN STATUS POST-SURGERY; WEAKNESS. ON (B)(6) 2012: PATIENT UNDERWENT LUMBAR MYELOGRAM. IMPRESSION: POSTOPERATIVE CHANGES AND LUMBAR SPONDYLOSIS. ON (B)(6) 2012: THE PATIENT UNDERWENT RENAL ULTRASOUND. IMPRESSION: NORMAL KIDNEYS, NO HYDRONEPHROSIS. MILD BLADDER DISTENTION AND MILD ENLARGED PROSTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155646 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111057AAI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention