BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3140475 · Received May 31, 2013

    Report

    Report Number
    1030489-2013-02036
    Event Type
    Injury
    Date Received
    May 31, 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL SURGERY AT C4-7 WITH INSTRUMENTATION, BMP AND VITOSS BONE. C5-C6; C6-7 POSTERIOR CERVICAL FORAMINOTOMY. POSTERIOR INSTRUMENTATION WAS IMPLANTED AT C4-7 WITH NO SCREW AT THE RIGHT SIDE OF C6 DUE TO POOR BONE MASS. BMP AND VITOSS WERE PLACED IN THE LATERAL GUTTER. PX C SPINE PORTABLE (B)(6) 2007: THE CEPHALAD PORTION OF A FUSION PLATE IS IDENTIFIED AT THE C4 LEVEL. THE CAUDAL PORTION OF THE DEVICE IS OBSCURED. IN ADDITION THE CEPHALAD ASPECT OF THE POSTERIOR FUSION DEVICE AT THE C4 LEVEL IS SO IDENTIFIED. THE UPPER CERVICAL SPINE APPEARS UNREMARKABLE. (B)(6) 2008: BILATERAL OCCIPITAL NERVE BLOCK PERFORMED SURGERY (B)(6) 2009: REMOVAL OF PREVIOUS ANTERIOR PLATE TO EVALUATION PREVIOUS FUSION. ANT CERVICAL DISCECTOMY AT C3-4. PEEK GRAFT FOR ARTHRODESIS AT C3-4 PLATE IMPLANTED AT C3-4. POX C SPINE PORTABLE (B)(6) 2009: EXTENSIVE ANTERIOR AND POSTERIOR FUSION. INTERVAL PLACEMENT OF AN ANTERIOR SCREW-PLATE FIXATION DEVICE BRIDGING C3-4. SURGERY (B)(6) 2009 : PATIENT SUFFERING CERVICAL RADICULOPATHY AND EVIDENCE OF DISEASE AT C3. UNDERWENT SURGERY TO REMOVE PREVIOUS POSTERIOR INSTRUMENTATION. NEW SEGMENTAL INSTRUMENTATION IMPLANTED AT C3, C4-5, C5-6, C6-7. AFTER NEW HARDWARE AT C3-7, BMP AND VITOSS WERE PLACED IN THE LATERAL GUTTERS. CHEST X-RAY (B)(6) 2009: THE CHEST X-RAY REVEALS MILD ATELECTASIS (UNINTELLIGIBLE) OR PNEUMONIA IN BOTH UPPER LUNGS. (B)(6) 2009: PATIENT ADMITTED TO THE NEURO INTENSIVE CARE UNIT POST-OP. SHE WAS STABLE THROUGHOUT THE NIGHT; HOWEVER, DEVELOPED SOME HYPERTENSION IN THE MORNING AND WAS FOUND TO HAVE ELEVATED WHITE COUNT AND LOW-GRADE FEVER. AP PORTABLE CHEST X-RAY (B)(6) 2009: IN THE RIGHT UPPER LOBE, THERE IS AN AREA OF ¿____¿ MEASURING 2.7 X 4.3CM IN SIZE. THIS APPEARS MORE PROMINENT ON THE CURRENT EXAMINATION THAN THE PRIOR EXAM. THE LEFT LUNG APPEARS CLEAR.(B)(6) 2009 PATIENT EVALUATED FOR BRADYCARDIA POST-OP. THE PATIENT HAD REOCCURRING EPISODES OF BRADYCARDIA WITH PAUSES UP TO 3-3.5 SECONDS. PATIENT ALSO NOTED TO HAVE RIGHT SIDED DIAPHRAGMATIC PARALYSIS POST-OP. (B)(6) 2012: PATIENT ADMITTED TO HOSPITAL FOR AN IT PUMP TRIAL TO WHICH SHE RESPONDED WELL. PATIENT COMPLAINING THAT C1 AND C2 ARE ACTING UP AND PAIN HAS RECURRED. HAD STEROID INJECTIONS. HAS FAILED OUTPATIENT REHAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240830 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110610AAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other