BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5999211 · Received October 5, 2016

    Report

    Report Number
    1030489-2016-02755
    Event Type
    Injury
    Date Received
    October 5, 2016
    Report Date
    September 8, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2011 LEVELS IMPLANTED: C3-C4,C4-C5, C5-C6,C6-C7 TYPE OF PROCEDURE (INCLUDING APPROACH): ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF)- EXTRAPHARYNGEAL ANTEROLATERAL APPROACH INITIAL DIAGNOSIS: ACDF FOR TREATMENT OF DEGENERATIVE DISC DISEASE (DDD) ON (B)(6) 2011, PATIENT REPORTED MIGRATORY DYSESTHESIA (PAIN, BURNING), PARESTHESIAS (NUMBNESS, TINGLING), INVOLVING UPPER AND LOWER EXTREMITIES; EXACERBATED BY ACTIVITIES OF DAILY LIVING, FATIGUE. ON (B)(6) 2011, PATIENT UNDERWENT MRI W/O CONTRAST, CERVICAL SPINE. RESULTS: NORMAL. ON (B)(6) 2011, PATIENT UNDERWENT RADIOGRAPHIC TEST OF LATERAL CERVICAL SPINE FILMS. RESULTS: NORMAL. ON (B)(6) 2011, PATIENT UNDERWENT ELECTROMYELOGRAM, NERVE CONDUCTION STUDY (EMG/NCV). RESULTS: NORMAL. ON (B)(6) 2011, PATIENT UNDERWENT RADIOGRAPHIC TEST LATERAL CERVICAL SPINE FILMS. RESULTS: NORMAL. ON (B)(6) 2012, PATIENT UNDERWENT MRI W/O CONTRAST, CERVICAL SPINE. RESULTS: NORMAL. ON (B)(6) 2012, PATIENT UNDERWENT ELECTROMYELOGRAM, NERVE CONDUCTION STUDY (EMG/NCV). RESULTS: NORMAL. ON (B)(6) 2012, PATIENT REPORTED DISCOMFORT, INTERSCAPULAR, DYSESTHESIA (PAIN, WEAKNESS), PARESTHESIA (NUMBNESS) AFFECTING PREVIOUSLY UNAFFECTED AREAS OF RIGHT ARM AND DIGITS OF RIGHT HAND; EXACERBATED BY WORK-RELATED REPETITIVE MOTION. OVER NEXT MONTHS DIAGNOSTIC STUDIES CONFIRMED SUCCESSFUL C-SPINE FUSION W/O COMPLICATIONS <(>&<)> CONFIRMED RIGHT C-7, POSSIBLE C-8 RADICULOPATHY; NO FURTHER WORK UP/NEUROSURGICAL INTERVENTION INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653339 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other