BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2931077 · Received January 28, 2013

    Report

    Report Number
    1030489-2013-00262
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    December 27, 2012
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO TREAT L3-4, L4-5, L5-S1 DEGENERATED HERNIATED DISCS. PROCEDURE WAS FOR L3-4, L4-5, L5-S1 HEMILAMINECTOMIES, COMPLETE FACETECTOMIES L3-4, L4-5, L5-S1, DISCECTOMIES L3-4, L4-5, L5-S1, ANTERIOR ARTHRODESIS WITH PEEK CAGE, RHBMP-2/ACS, AND LEFT ILIAC CREST GRAFT, L3,4,5,S1 POSTEROLATERAL BILATERAL INSTRUMENTED FUSION WITH AUTOLOGOUS BONE GRAFT AND TITANIUM INSTRUMENTATION. THE DISC SPACE WAS FILLED WITH AUTOLOGOUS BONE AND BMP SOAKED SPONGE WAS PLACED INSIDE THE PEEK CAGE AT EACH LEVEL. TEN DAYS POST-OP, THE PHYSICIAN'S NOTES STATE THAT THE "PATIENT IS DOING QUITE WELL 11 DAYS STATUS POST TWO-LEVEL LUMBAR RE-EXPLORATION AND FUSION." TWENTY-SEVEN DAYS POST-OP, THE PHYSICIAN'S NOTES STATE THAT "FOR THE PAST ONE TO TWO WEEKS HE HAS BEEN HAVING NEW ONSET OF LEFT LEG NUMBNESS. I INFORMED THE PATIENT THAT THIS MAY DUE TO THE FACT THAT THE NERVE IS STILL HEALING FROM HIS SURGERY." FORTY-ONE DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, THE PATIENT "RETURNS BACK AND IS HAVING A SLOW RECOVERY. HE DOES WALK WITH A CANE. HE DOES HAVE SOME NUMBNESS IN HIS ANTERIOR THIGHS GOING OVER TO HIS KNEES. HE ALSO HAS SOME NUMBNESS GOING DOWN IN THE CALF INTO THE LATERAL ASPECT OF THE RIGHT FOOT." SEVENTY-TWO DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, "HE IS CONTINUING TO HAVE DIFFICULTIES. THE PATIENT IS NOW APPROXIMATELY TEN WEEKS OUT FROM HIS SURGERY. HE CONTINUES TO COMPLAIN LARGELY OF THE NUMBNESS IN THE LATERAL ASPECT OF THE RIGHT FOOT, NOT PAIN, BUT THAT NUMBNESS NEVERTHELESS KEEPS HIM UP AT NIGHT. IN ADDITION TO THAT, ACCORDING TO THE PHYSICAL THERAPY HE HAS WEAKNESS IN THE LOWER EXTREMITIES." "X-RAYS WERE PERFORMED, WHICH SHOW THE INSTRUMENTATION IN ADEQUATE POSITION. THE ALIGNMENT IS NORMAL AND MAINTAINING HEIGHT. THERE APPEARS TO BE NO OVERT ABNORMALITIES WITH THIS X-RAY." AT 105 DAYS POST-OP, THE PATIENT PRESENTED "WITH NUMBNESS PERSISTING IN HIS LOWER EXTREMITIES. HE CONTINUES TO AMBULATE WITH A CANE. HE ALSO HAS BEEN THROUGH PHYSICAL THERAPY APPARENTLY MAKING REASONABLY GOOD PROGRESS BUT SLOW PROGRESS." AT 162 DAYS POST-OP, THE PATIENT PRESENTED FOR CONSULTATION WITH PARATHESIS OF HIS HANDS AND GAIT IMBALANCE. SINCE SURGERY THE PATIENT HAS DEVELOPED SOME PARESTHESIAS AND NUMBNESS IN REGARDS TO THE LEFT LEG PARTICULARLY INVOLVING THE ANTERIOR LATERAL SURFACE. PARASTHESIAS AND DYSESTHESIAS IN REGARDS TO BOTH HANDS PARTICULARLY NOTED ON THE LEFT. THE PATIENT NOTES DIFFICULTY AMBULATING DUE TO BACK DISCOMFORT. ELECTRODIAGNOSTIC FINDINGS INDICATED "EVIDENCE OF ULNAR NERVE NEUROPATHIES IN REGARDS TO THE ELBOW SEGMENTS AND IMMEDIATELY BELOW." "MILD RIGHT CARPAL TUNNEL SYNDROME." AT 170 DAYS POST-OP, A CERVICAL MRI WAS INTERPRETED TO INDICATE "NO EVIDENCE OF ACUTE INFARCTION OR FOCAL MASS OR ABNORMAL GADOLINIUM ENHANCEMENT. FEW SMALL PUNCTATE T2 BRIGHT SIGNAL FOCI IN THE SUBCORTICAL WHITE MATTER ESPECIALLY LEFT POSTERIOR FRONTAL AND BOTH PARIETAL LOBES. THIS IS A NONSPECIFIC FINDING AND COULD BE SEEN IN MIGRAINE." A THORACIC MRI WAS INTERPRETED TO INDICATE "NO EVIDENCE FOR ABNORMAL T2 BRIGHT SIGNAL WITHIN THE THORACIC SPINAL CORD. NO CORD COMPRESSION. NO ABNORMAL MENINGEAL GADOLINIUM ENHANCEMENT." REPORTEDLY, AT AN UNKNOWN TIME POST-OP, THE PATIENT ALLEGEDLY EXPERIENCED NERVE DAMAGE, LOSS OF BALANCE, NUMBNESS AND WEAKNESS IN LEFT LEG, RADIATING PAIN, AND INABILITY TO SIT AND STAND FOR LONG PERIODS OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37499 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110807AAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other