BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2994384 · Received March 8, 2013

    Report

    Report Number
    1030489-2013-00704
    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, DOI:10.1097/BSD.0B013E318286FA7E. IMPLANT: (B)(6) 2002 - (B)(6) 2007. (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 IN A LITERATURE PUBLICATION THAT A PROSPECTIVELY COLLECTED PATIENT DATABASE WAS REVIEWED FOR THOSE WHO UNDERWENT POSTERIOR CERVICAL, OCCIPITOCERVICAL, OR CERVICOTHORACIC INSTRUMENTED FUSION. 57 PATIENTS SATISFIED INCLUSION CRITERIA. FIFTY-SEVEN CONSTRUCTS INCLUDED 321 MOTION SEGMENTS. THE MEAN FOLLOW-UP WAS 37.7 ± 20.6 MONTHS (RANGE, 24-79). POSTOPERATIVELY, 51 PATIENTS (89.5%) DEVELOPED FUSION. ONE PATIENT PRESENTED WITH PAIN AND INSTABILITY. HE UNDERWENT OCC-C2 POSTERIOR CERVICAL FUSION. POST-OP, THE PATIENT DEVELOPED A NON-UNION AT C2 IDENTIFIED BY LUCENCY AT THE SITE. THE PATIENT EXPERIENCED NO NONUNION-RELATED SYMPTOMS. THE CASE WAS MANAGED EXPECTANTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100244 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 00056 YR Required Intervention