BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3122361 · Received May 21, 2013

    Report

    Report Number
    1030489-2013-01805
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    March 3, 2018
    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)(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.

    Additional Manufacturer Narrative · 1

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

    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 SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: INTRACTABLE LOW BACK PAIN. LUMBAR RADICULOPATHY. DISC HERNIATION L4-5. DEGENERATIVE DISC DISEASE L4-5 AND L5-S1 AND UNDERWENT THE FOLLOWING PROCEDURES: PLACEMENT OF FOLEY CATHETER. ANTERIOR DISCECTOMY AND EXCISION OF HERNIATION AT THE L4-5 INTERSPACE. ANTERIOR FUSION OF L4-5 AND L5-S1 INTERSPACES. PLACEMENT OF SYNFIX IMPLANT AT L4-5 AND L5-S1. PLACEMENT OF ANTERIOR SPINAL HARDWARE AT L4-5 AND L5-S1. FLUOROSCOPY GREATER THAN 1 HOUR. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. FINDINGS: A DISCECTOMY WAS PERFORMED AT L4-5 TO REMOVE A BROAD BASED HERNIATION. THE PLL WAS EXCISED TO ACCESS THE HERNIATION. THERE WAS SIGNIFICANT EPIDURAL BLEEDING CONTROLLED WITH BIPOLAR CAUTERY AND HEMOSTATIC AGENTS. AT L4-5 AN 19 MM, 8 DEGREE SYNFIX IMPLANT WAS PLACED. AT L5-S1 A 19 MM, 8 DEGREE SYNFIX IMPLANT WAS PLACED. AN ANTERIOR PLATE WITH FOUR DIVERGING TITANIUM SCREWS WAS USED AT EACH LEVEL TO SECURE THE IMPLANT. RHBMP-2 AND PUTTY WERE USED AT EACH LEVEL WITHIN THE STRUCTURAL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224262 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