BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2994455 · Received March 8, 2013

    Report

    Report Number
    1030489-2013-00707
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: DORWARD ET AL. POSTERIOR CERVICAL FUSION WITH RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2: COMPLICATIONS AND FUSION RATE AT MINIMUM TWO-YEAR FOLLOW-UP. BSD JOURNAL OF SPINAL DISORDERS AND TECHNIQUES; 2013, (B)(4). NON-UNION. 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 IN A LITERATURE PUBLICATION THAT A PROSPECTIVELY COLLECTED PATIENT DATABASE WAS REVIEWED FOR THOSE WHO UNDERWENT POSTERIOR CERVICAL, OCCIPITOCERVICAL, OR CERVICOTHORACIC INSTRUMENTED FUSION. FIFTY-SEVEN PATIENTS SATISFIED INCLUSION CRITERIA. FIFTY-SEVEN CONSTRUCTS INCLUDED 321 MOTION SEGMENTS. THE MEAN FOLLOW-UP WAS ((B)(6)). POSTOPERATIVELY, 51 PATIENTS (89.5%) DEVELOPED FUSION. ONE PATIENT PRESENTED WITH CERVICAL RADICULOPATHY, RHEUMATOID ARTHRITIS AND BASILAR INVAGINATION. SHE UNDERWENT OCC-C4 POSTERIOR CERVICAL FUSION WITH ILIAC CREST AUTOGRAFT AND RHBMP-2. SIX YEARS POSTOPERATIVELY, THE PATIENT PRESENTED WITH RIGHT UPPER EXTREMITY NUMBNESS AND WEAKNESS, AND IMAGING REVEALED PSEUDARTHROSIS AT C3/4 (IDENTIFIED BY LUCENCY AND MOTION ON F/E) AND MULTIPLE SUBLUXATIONS FOR WHICH A C3-C7 ACDF WITH C5 CORPECTOMY AND RHBMP-2 WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99044 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 00059 YR Required Intervention