BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3143520 · Received June 3, 2013

    Report

    Report Number
    1030489-2013-02067
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 23, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE USED 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. (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES OR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 ALLEGEDLY SUSTAINED UNSPECIFIED INJURIES RESULTING FROM A SPINAL FUSION SURGERY USING RHBMP-2/ACS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2010: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: RECURRENT HERNIATED NUCLEUS PULPOSUS, RIGHT L4-5. LUMBAR RADICULITIS, RIGHT LOWER EXTREMITY. DEGENERATIVE LUMBAR DISC DISEASE, L4-5. LUMBAR INSTABILITY, L4-5. PATIENT UNDERWENT FOLLOWING PROCEDURE: REENTRY DECOMPRESSIVE LAMINECTOMY WITH RIGHT L4 AND L5 FORAMINOTOMIES. POSTEROLATERAL FUSION, L4-5. POSTERIOR INSTRUMENTATION, L4-5 WITH SPINAL USA TITANIUM HARDWARE. AS PER OP-NOTES: NICE DECOMPRESSION OF THE FORAMINA WAS ACCOMPLISHED BILATERALLY. 6.5 X 40 MM PEDICLE SCREWS WERE PLACED USING FLUOROSCOPIC GUIDANCE TO CONFIRM THAT ALL FOUR SCREWS WERE IN GOOD POSITION. RODS WERE APPLIED. DECORTICATION OF FACETS AND TRANSVERSE PROCESSES ALLOWED FOR PLACEMENT OF SMALL RHBMP-2/ACS KIT WITH ONE SPONGE LATERALLY ALONG WITH 60 CC OF ALLOGRAFT AND LOCAL BONE. FINAL X-RAYS SHOWED GOOD POSITION OF ALL HARDWARE AND DURAL TEARS WERE ENCOUNTERED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT A DECOMPRESSIVE LAMINECTOMY WITH RIGHT L4 AND L5 FORAMINOTOMIES, POSTEROLATERAL FUSION L4-5, AND A POSTERIOR INSTRUMENTATION L4-5. IT WAS REPORTED THAT RHBMP-2/ACS WAS USED. ON (B)(6) 2010, THE PATIENT UNDERWENT AN ANTERIOR RETROPERITONEAL EXPOSURE AND ANTERIOR INTERBODY FUSION OF L4-5. THE PATIENT NOW SUFFERS FROM UNSPECIFIED INJURIES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243449 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 34 YR Other| R