BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3071051 · Received April 22, 2013

    Report

    Report Number
    1030489-2013-01182
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    May 8, 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. 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

    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 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 PER PATIENT¿S MEDICAL RECORDS THAT ON: (B)(6) 2004: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OPERATIVE DIAGNOSIS: LOW BACK PAIN AND BILATERAL LUMBAR RADICULOPATHY. HE UNDERWENT THE FOLLOWING PROCEDURES: L4 LAMINECTOMY AND BILATERAL MEDIAL FACETECTOMY AND FORAMINOTOMY. REDO RIGHT L5 LAMINECTOMY, BILATERAL MEDIAL FACETECTOMY AND FORAMINOTOMY. REDO LEFT L5 LAMINECTOMY, BILATERAL MEDIAL FACETECTOMY AND FORAMINOTOMY. REDO RIGHT S1 LAMINECTOMY, BILATERAL MEDIAL FACETECTOMY AND FORAMINOTOMY. REDO LEFT S1 LAMINECTOMY, BILATERAL MEDIAL FACETECTOMY AND FORAMINOTOMY. POSTERIOR LUMBAR INTERBODY FUSION, L4-5, L5-S1. POSTEROLATERAL ARTHRODESIS, L4-5, L5-S1. PLACEMENT OF INTERBODY ALLOGRAFT PEEK CAGES, L4-5, L5-S1. PEDICLE SCREW FIXATION L4 TO S1 USING SEGMENTAL PEDICLE SCREW SPIRAL 90D. PLACEMENT OF ALLOGRAFT AND AUTOGRAFT MORSELIZED BONE HARVESTING. USE OF NAVIGATION SYSTEM. AS PER THE OP NOTES, ¿¿A 45 MM SCREW WAS PLACED, BOTH IN L4 AND L5, AND A 40 MM SCREW WAS PLACED IN S1. AFTER THIS, A ROD WAS CHOSEN. IT WAS CONTOURED INTO PLACE. IT WAS LOCKED DOWN WITH THE SET SCREWS AND TORQUED TO THE APPROPRIATE LEVEL. AN X-RAY WAS PERFORMED CONFIRMING POSITION. THE INTERBODY CONNECTOR WAS PLACED. RHBMP-2 WAS THEN PLACED IN THE LATERAL GUTTERS. ALL SCREWS WERE TORQUED TO AN APPROPRIATED LEVEL¿ AN X-RAY WAS PERFORMED, CONFIRMING POSITION¿¿ NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173170 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M114005AAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other