BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2861615 · Received December 7, 2012

    Report

    Report Number
    1030489-2012-02658
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    October 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).

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT HAS DEVELOPED "SERIOUS INJURY INCLUDING PAIN AND PHYSICAL LIMITATIONS."

    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 ON (B)(6) 2006, THE PATIENT WAS ADMITTED TO THE FACILITY WHERE THE PATIENT UNDERWENT SPINE FUSION SURGERY USING RHBMP-2 ON THE CERVICAL REGION OF SPINE FROM VERTEBRAE C5 TO C7. THE RHBMP-2 COLLAGEN SPONGE WAS USED TO FUSE MORE THAN ONE LEVEL OF THE SPINE.THE RHBMP-2 COLLAGEN SPONGE WAS PLACED OUTSIDE A CAGE. POST-OP, PATIENT REPORTEDLY HAD PROGRESSIVELY WORSENING PAIN IN HIS NECK, LEFT ARM AND BACK, AND DIFFICULTY SWALLOWING. PATIENT CONTINUES TO EXPERIENCE CHRONIC LEFT-SIDED NECK PAIN, WITH PAIN RADIATING TO HIS LEFT ARM AND CHEST AREA, MUSCLE SPASMS, NUMBNESS AND TINGLING THROUGHOUT HIS LEFT SIDE, AND SWELLING IN HIS LOWER EXTREMITIES. PATIENT ALSO REPORTEDLY SUFFERS FROM LIMITED MOBILITY, DIFFICULTY BREATHING AND SLEEP APNEA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2006: THE PATIENT UNDERWENT FUSION SURGERY AND RH BMP-2/ACS WAS IMPLANTED. AS PER THE OP NOTES: ¿THIS WAS DONE FROM C5 THROUGH C7 ALSO. RHBMP-2/ACS WAS PLACED INTO THE FACET JOINTS AS WELL AS IN THE INTERLAMINAR AREA PRIOR TO PLACEMENT OF BONE GRAFT. FINDINGS: MOTION ABOUT THE FACET JOINTS AT C6-C7 CONSISTENT WITH AN INCOMPLETE ARTHRODESIS.¿ 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