BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3133819 · Received May 29, 2013

    Report

    Report Number
    1030489-2013-01906
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    April 27, 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.

    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 FOLLOWING PRE-OP DIAGNOSIS: SEVERE DEBILITATING LUMBAR /LUMBOSACRAL STRAIN, MECHANICAL LOW BACK PAIN, WORK-RELATED. LEFT LOWER EXTREMITY LUMBAR RADICULOPATHY GREATER THAN RIGHTIN A L5-S1 DISTRIBUTION, WORK-RELATED. LUMBAR DISK HERNIATION L5-S1 LEVEL, WORK-RELATED LIFTING ACCIDENT. MODERATE LUMBAR DEGENERATIVE DISK DISEASE L5-S1 LEVEL, DISCOGENIC PAIN, HERNIATED NUCLEUS PULPOSUS. DEVELOPMENT OF INTRACTABLE BACK PAIN, LEG PAIN ASSOCIATED WITH THE ABOVE. HE UNDERWENT FOLLOWING PROCEDURES: L5-S1 LEVEL ANTERIOR LUMBAR RETROPERITONEAL APPROACH DECOMPRESSIVE DISKECTOMY, PARTIAL CORPECTOMY L5-S1 LEVEL. ANTERIOR LUMBAR L5-S1 LEVEL INTERBODY FUSION UTILIZING AUTOLOGOUS BONE GRAFT AS WELL AS A MEDIUM BONE MORPHOGENIC PROTEIN GRAFT, L5-S1 LEVEL. ANTERIOR LUMBAR INTERBODY STABILIZATION AT THE L5-S1 LEVEL WITH PLACEMENT OF TWO PEEK LT CAGE INTERBODY FIXATION DEVICES AT THE L5-S1 LEVEL UNDER BIPLANAR FLUOROSCOPY. LEFT ILIAC CREST BONE GRAFT HARVEST THROUGH SEPARATE SKIN AND FASCIAL INCISION. INTRAOPERATIVE FLUOROSCOPY WITH INTERPRETATION. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235774 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