BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2832186 · Received November 14, 2012

    Report

    Report Number
    1030489-2012-02190
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    June 13, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    ADDITIONAL INFORMATION: TWO QUANTITIES OF THE SAME PRODUCT HAS BEEN REPORTED FOR THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON (B)(6) 2010: OFFICE VISIT CHIEF COMPLAINT: STARTED HAVING PROBLEMS IN (B)(6) OF BACK PAIN AND LEFT ANTERIOR LEG PAIN. HAS BEEN TAKING ANTI-INFLAMMATORIES, BEEN TO THE EMERGENCY ROOM, AND GIVEN MOBIC, LORATAB, AND FLEXERIL. THE MEDICATIONS HAVE HELPED NOMINALLY. PAIN IS RANKED AT 8 OUT OF 10. MOSTLY HAS SHARP PAINS IN THE BACK AND SOME BURNING PAIN DOWN THE LEFT ANTERIOR THIGH. PHYSICAL EXAM SHOWED SOME PAIN WITH FLEXION. X-RAYS SHOWED MILD DEGENERATIVE CHANGES BUT NO LISTHESIS IS NOTED. ON (B)(6) 2010: OFFICE VISIT PATIENT STILL HAS BACK PAIN FOLLOWING AN INJURY AT WORK IN SEPTEMBER, PATIENT HAS BACK AND LEG PAIN DESPITE UNDERGOING PHYSICAL THERAPY AND MEDICAL THERAPY. SCHEDULED AN MRI WITH FOLLOW UP APPOINTMENT AFTER. ON (B)(6) 2010: MRI LUMBAR SPINE TRACE REACTIVE MARROW EDEMA IS SEEN AS WELL AS SCLEROSING ALONG THE INFERIOR ENDPLATE OF L5. BULGE SEEN AT L2-3, L3-4 SHOWS PROTRUDED DISK MATERIAL, L4-5 SUBTLE ANNULAR BULGE. L5-S1 MODERATE BROAD BASED SUBLIGAMENTOUS HERNIATION IS PRESENT. APPARENT CHOLELITHIASIS. ON (B)(6) 2010: FOLLOW UP MRI, SHOWS DISC BULGES IN THE UPPER LUMBAR REGION. MAIN PROBLEM IS AT L5-S1 WHERE THERE IS A DEGENERATIVE DISC HERNIATION. MODERATE AMOUNT OF STENOSIS. PHYSICAL AND CONSERVATIVE THERAPY ORDERED. ON (B)(6) 2010: L5-S1 EPIDURAL DONE. ON (B)(6) 2011: MRI FOLLOW UP AND REVIEW NOTED: DEGENERATIVE DISC DISEASE L5-S1 AND HERNIATION, STENOSIS, AND RIGHT LEG PAIN HAD DISCUSSION WITH PATIENT AND DETERMINED SURGERY,FUSION IS BEST OPTION. ON (B)(6) 2011: FOLLOW UP FOR LUMBAR SPONDYLOSIS, RIGHT PARACENTRAL DISC HERNIATION AT L5-S1 WITH RADICULAR SYMPTOMS, PARTICULARLY ON THE LEFT. PATIENT HAS DECIDED TO PROCEED WITH SURGERY. FUSION, DECOMPRESSION, LAMINECTOMY, DISCECTOMY L5-S1. ON (B)(6) 2011: LUMBAR SPINE LAMINECTOMY, BILATERAL DECOMPRESSION L5-S1 (B)(6) 2011: POST-OP CHECKUP, MRI LUMBAR SPINE, REVISION, WOUND IRRIGATION AND EXTENSION OF DECOMPRESSION EPIDURAL FLUID COLLECTION SEEN EXTENDING INTO THE OPERATIVE SITE AT L5-S1 DIAGNOSIS: WOUND HEMATOMA, LUMBAR WOUND, EPIDURAL EXTENSION, CSF LEAK PATIENT TAKEN TO SURGERY FOR EVALUATION OF WOUND AND DRAINAGE/CLEANING NO OBVIOUS CSF LEAK WAS NOTED, HEMATOMA WAS FOUND, WOUND WAS IRRIGATED (B)(6) 2011: POST-OP FOLLOW UP. PATIENT SENT FOR ULTRASOUND TO RULE OUT DVT, HAS SEEN EXCELLENT DECREASE IN LEG SYMPTOMS ALTHOUGH STILL REPORTS TINGLING SENSATION IN ANTERIOR ASPECT OF LEFT THIGH AND SOME CALF PAIN. WILL FOLLOW UP IN ONE MONTH. GIVEN NEURONTIN AND MEDROL DOSEPAK. ON (B)(6) 2011: POST-OP FOLLOW UP PATIENT IS AMBULATING WELL STILL REPORTS SOME RADICULAR NUMBNESS IN LEFT FOOT BUT NO PROBLEMS WITH LOWER EXTREMITIES. EXAM LOOKS GOOD, REMOVED STERI STRIPS SKIN HEALING WELL NO SIGNS OF INFECTION. FOLLOW UP IN ONE MONTH. RELEASED PATIENT TO NORMAL ACTIVITIES. ON (B)(6) 2011: ER VISIT WITH BACK PAIN POST ¿OP MRI OF LUMBAR SPINE FINDINGS: SCREWS IN L5-S1 PEDICLES, VERTEBRAL ALIGNMENT IS NORMAL, MILD DDD AT L5-S1. NO OTHER ABNORMALITIES NOTED. ON (B)(6) 2011: ER VISIT, CHEST PAIN, SHORTNESS OF BREATH, VOMITING FINDINGS: PICC LINE, HEART IS NORMAL, LUNGS ARE NORMAL, NO PLEURAL EFFUSION, IMPRESSION: NO ACUTE CARDIOPULMONARY DISEASE, PATIENT HAS RIGHT UPPER EXTREMITY PICC LINE. ON (B)(6) 2011: POST OP CHECKUP. NO MORE LEG PAIN, PATIENT DOING REALLY WELL. OFF MEDICATION NOW. NO WORSENING SYMPTOMS. HAS SOME MILD BACK PAIN BUT NOTHING ELSE. X-RAYS LOOK GOOD. NO ABNORMALITIES. START PATIENT ON PT AND SEE BACK IN TWO MONTHS. ON (B)(6) 2011: POST OP CHECKUP. PATIENT STATES OCCASIONAL SPASMS IN LEGS BUT BETTER THAN BEFORE SURGERY. EXAMS ALL LOOK GOOD. WILL SEE BACK IN THREE MONTHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2011 AND UNDERWENT FUSION SURGERY IN WHICH RHBMP2/ACS WAS USED. SHE GOT DISCHARGED ON (B)(6) 2011.

    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 M111057AAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other