BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3011130 · Received March 19, 2013

    Report

    Report Number
    1030489-2013-00782
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    July 1, 2011
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED FOR SURGERY TO REVISE A FRACTURED RIGHT-SIDED ROD WITH ADDITION OF PEEK INTERBODY GRAFT AT L2-L3 RH-BMP2/ACS. BMP WAS PLACED IN THE DISC SPACE AND IN THE CAGE, AND WAS PLACED LATERALLY ON BOTH SIDES POSTERIORLY. IN THE WEEKS FOLLOWING SURGERY, THE PT REPORTS ONSET OF NEW SYMPTOMS OF RLE PAIN AND NUMBNESS. MRI SHOWS "FLUID COLLECTION WITHIN THE POSTERIOR SOFT TISSUES EXTENDING FROM L1 TO THE S1 LEVEL, WHICH MOST LIKELY REPRESENTS POST-OPERATIVE FLUID COLLECTION." IMAGING ONE MONTH POST-OP SHOWS INSTRUMENTATION INTACT. NOTES INDICATE PT. "HAS GOTTEN A NEW MRI OF THE BACK WHICH SHOWS THE FLUID MASS THAT WE KNOW IS PRESENT AND, FOR SOME REASON, HIS SED RATE HAS GONE UP. HE FEELS AS IF HE HAS HAD SOME SPASMS DOWN HIS BACK AND PAIN DOWN HIS LEG." PT HAD CT GUIDED ASPIRATION OF THE L2-3 DISC SPACE. SMALL AMOUNT OF FAIRLY CLEAR LIQUID WAS OBTAINED. CULTURE GREW COAGULASE-NEGATIVE STAPHYLOCOCCUS AND PT WAS STARTED ON INTRAVENOUS ANTIBIOTICS. PT BACK SYMPTOMS IMPROVED SIGNIFICANTLY FOR APPROXIMATELY 1 YEAR THEN THE PATIENT BEGAN HAVING PINCHING LIKE PAIN IN THE RIGHT ABDOMINAL THORACIC AREA AND SENSATION CHANGES IN THE RIGHT SIDE RADIATING TO THE RIGHT SIDE OF HIS MID BACK AREA. THE PT. WAS DIAGNOSED WITH DISKITIS. APPROXIMATELY 16 MONTHS POST-OP, THE PT PRESENTED FOR SURGERY WITH INSTABILITY WITH RADICULOPATHY ABOVE PREVIOUS T10 TO SACRAL FUSION WITH DESTRUCTION OF T9-T10 INTERSPACE. OPERATION WAS FOR EXTENSION OF PREVIOUS FUSION TO T8 WITH POSTERIOR INSTRUMENTATION WITH PEDICLE FIXATION AND INTERBODY GRAFT AT T9-T10 WITH PEEK GRAFT FILLED WITH BONE GRAFT AND DBM. DURING SURGERY, IT WAS FOUND THAT THE UPPER PEDICLE SCREWS WERE LOOSE IN THE VERTEBRAL BODY AND MAY HAVE ERODED INTO THE T9-T10 DISC SPACE. T10 SCREWS WERE REMOVED AND PEDICLE SCREWS WERE PLACED AT T8 AND T9 BILATERALLY. BONE GRAFT, DBM, AND BCP WERE PLACED ON EACH SIDE AT T8 AND T9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114171 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111057AAL

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention PEEK CAGE, PEDICLE SCREWS