BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2612839 · Received June 12, 2012

    Report

    Report Number
    1030489-2012-00926
    Event Type
    Injury
    Date Received
    June 12, 2012
    Report Date
    December 27, 2017
    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). 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. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. 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

    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 SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SUR GERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT HAS DEVELOPED "PAIN AND A LIMITED MOBILITY. [PATIENT] WORRIED ABOUT THINGS GETTING WORSE. ABNORMAL BONE GROWTH."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2011: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL STENOSIS AND PROGRESSIVE CERVICAL SPONDYLITIC UNDERWENT THE FOLLOWING PROCEDURES: PLACEMENT OF POSTERIOR SEGMENTAL INSTRUMENTATION AT C3, C4, C5, C6, C7 AND T1 BILATERALLY (6 LEVELS). POSTERIOR SPINAL FUSION AT C3-4, C4-5, C5-6, C6-7, AND C7-T1 (5 LEVELS). LAMINECTOMY AT C4, C5, C6, AND C7 (4 LEVELS). HARVEST OF LOCAL AUTOGENOUS BONE GRAFT. AS PER OPERATIVE NOTES,¿ EXPOSURE WAS CARRIED OUT TO THE TIPS OF THE LATERAL MASSES BILATERALLY, OUT TO THE TIPS OF THE TRANSVERSE PROCESSES AND T1 BILATERALLY. SEGMENTAL INSTRUMENTATION WAS PLACED FROM C3- T1 BILATERALLY, LATERAL MASS SCREWS AT C3, C4, C5, C6, AND C7 BILATERALLY, THORACIC PEDICLE SCREWS AT T1 BILATERALLY. ALL SCREWS GAVE REASONABLY GOOD PURCHASE. THE PATIENT WAS SOMEWHAT OSTEOPOROTIC. WITH FIXATION POINTS ALL IN GOOD POSITION, A HIGH- SPEED DRILL WAS USED, LEKSELL RONGEURS , AND VARIOUS KERRISON RONGEURS TO PERFORM A LAMINECTOMY AT C4, C5, C6, AND C7.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R