BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3102387 · Received May 9, 2013

    Report

    Report Number
    1030489-2013-01611
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 9, 2013
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: RODGERS SD ET AL. REVISION SURGERY AFTER INTERBODY FUSION WITH RHBMP-2: A CAUTIONARY TALE FOR SPINE SURGEONS: CASE REPORT. J NEUROSURG: SPINE; APRIL 5, 2013. (DOI: 10.3171/2013.3.SPINE12377). (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 IN A LITERATURE PUBLICATION THAT THE PATIENT PRESENTED WITH A 1-YEAR HISTORY OF WORSENING INTRACTABLE LOW-BACK PAIN WITH NEUROGENIC CLAUDICATION. THE PATIENT COMPLAINED OF PAIN THAT RADIATED BILATERALLY DOWN HIS LOWER EXTREMITIES INTO HIS FEET WITH ASSOCIATED NUMBNESS AND TINGLING; HE DENIED ASSOCIATED WEAKNESS. HIS PAIN PREVENTED HIM FROM STANDING UP STRAIGHT, WORSENED WHEN HE WAS SITTING DOWN OR STANDING UP, AND WAS RELIEVED WHILE LYING DOWN. THE PATIENT DENIED BOWEL AND BLADDER DYSFUNCTION OR SADDLE PARESTHESIAS. NEUROLOGICAL EXAMINATION REVEALED GRADE 5/5 MOTOR STRENGTH THROUGHOUT HIS BILATERAL LOWER EXTREMITIES. SENSATION TO LIGHT TOUCH AND PINPRICK WAS INTACT IN THE LOWER-EXTREMITY DERMATOMES. THERE WAS NO PAIN ON HIP RANGE OF MOTION, AND A STRAIGHT-LEG-RAISE MANEUVER WAS NEGATIVE BILATERALLY. ON RADIOGRAPHIC IMAGING THE PATIENT WAS FOUND TO HAVE SPONDYLOSIS WITH A GRADE 1 SPONDYLOLISTHESIS (ACCORDING TO THE MEYERDING GRADING SCALE) AT L4/5, WITH LUMBAR STENOSIS MOST SEVERE AT L3/4 AND L4/5. THE PATIENT UNDERWENT AN UNCOMPLICATED L3/5 LAMINECTOMY AND POSTEROLATERAL FUSION AT L2/5 WITH AN L4/5 TLIF. A LAMINECTOMY AND BILATERAL DECOMPRESSION OF THE LATERAL GUTTERS WERE PERFORMED TO RELIEVE THE LUMBAR LATERAL RECESS STENOSIS. THE HERNIATED DISC WAS EXCISED DURING THE LEFT-SIDED L4/5 TLIF DECOMPRESSING THE L-4 AND L-5 NERVE ROOTS. THE L4/5 DISC SPACE WAS RECONSTRUCTED USING AN INTERBODY POLYETHERETHERKETONE CAGE THAT WAS PACKED WITH 3 MG OF RHBMP-2 ON AN ABSORBABLE SPONGE, ALONG WITH CANCELLOUS BONE CHIPS. IN ADDITION, AUTOLOGOUS BONE GRAFT, CANCELLOUS BONE CHIPS, AND DEMINERALIZED BONE MATRIX WERE PLACED ANTERIORLY IN THE DISC SPACE. AFTER IRRIGATION OF THE WOUND, THE AUTOLOGOUS BONE GRAFT WAS PLACED INTO THE POSTEROLATERAL GUTTER BILATERALLY, WITH ADDITION OF 1 MG OF RHBMP-2 IN THE RIGHT POSTEROLATERAL GUTTER. INTOTAL 4.2 MG OF RHBMP-2 WAS USED. THE FINAL CONSTRUCT CONSISTED OF A L2/5 POSTEROLATERAL PEDICLE SCREW FIXATION WITH POSTEROLATERALFUSION AND LEFT L4/5 TLIF. POSTOPERATIVELY, THE PATIENT'S NEUROGENIC CLAUDICATION GREATLY IMPROVED AND HIS MECHANICAL BACK PAIN IMPROVED SLIGHTLY. WITHIN THE NEXT YEAR AND A HALF THE PATIENT RETURNED WITH UNREMITTING LOW-BACK PAIN AND NEUROGENIC CLAUDICATION THAT DID NOT RESPOND TO CONSERVATIVE MEASURES INCLUDING PHYSICAL/OCCUPATIONAL THERAPY, PAIN MANAGEMENT, AND EPIDURAL STEROID INJECTIONS.THE PATIENT NOW COMPLAINED OF UNREMITTING PAIN RADIATING BILATERALLY DOWN HIS LOWER EXTREMITIES, WORSE IN THE SHINS, WITH ASSOCIATED NUMBNESS AND TINGLING BUT WITHOUT WEAKNESS. THE PAIN SEVERELY LIMITED AMBULATION AND RESTRICTED HIS WORK AS A REAL ESTATE AGENT. THE PATIENT DENIED BOWEL AND BLADDER DYSFUNCTION OR SADDLE PARESTHESIAS. THE RESULTS OF A NEUROLOGICAL EXAMINATION WERE UNCHANGED. ONRADIOGRAPHIC IMAGING THE PATIENT WAS FOUND TO HAVE MULTILEVEL DEGENERATIVE CHANGES INCLUDING L4/5 GRADE 1 ANTEROLISTHESIS (MEYERDING SCALE) AND BILATERAL FORAMINAL NARROWING OF L5/S1. IN ADDITION, SCREW LUCENCY AT L-4 AND L-5 WAS NOTED ON IMAGING. THESE FINDINGS WERE CONSISTENT WITH L4/5 AND L5/S1 INSTABILITY AND PSEUDARTHROSIS. THE PREVIOUS FIXATION DID NOT PROGRESS TO FUSION, AND HE COMPLAINED OF SIGNIFICANT RECURRENT SYMPTOMS. THE DECISION WAS MADE TO PROCEED WITH A COMBINED ANTERIOR AND POSTERIOR APPROACH. THE PATIENT WAS SCHEDULED FOR AN ALIF AT L4/5 AND L5/S1 FOLLOWED BY A POSTEROLATERAL FUSION OF T-10 TO THE PELVIS DUE TO HIS ADJACENT SEGMENT DEGENERATION AT L1/2 AND L5/S1 WITH PSEUDARTHROSIS AT L4/5. DURING THE RETROPERITONEAL APPROACH, THE EXPERIENCED VASCULAR TEAM REFLECTED THE ABDOMINAL CONTENTS MEDIALLY TO EXPOSE THE L5/S1 DISC SPACE. FURTHER DISSECTION MOBILIZED THE LEFT AND RIGHT ILIAC ARTERIES TO THE AORTIC BIFURCATION. HOWEVER, THE ILIAC VEIN WAS ADHERED WITH SCARRING AND FIBROSIS DOWN TO THE PREVIOUSLY OPERATED L-4 AND L-5 VERTEBRAE. CAREFUL DISSECTION WAS USED TO MOBILIZE THE VEIN OFF OF THE VERTEBRAL BODY, BUT DURING MOBILIZATION THE LEFT ILIAC VEIN WAS TORN. THE DORSAL ASPECT OF THE VEIN WAS PROFOUNDLY ADHERENT TO THE L4/5 INTERSPACE AND BECAME SEPARATED FROM THE REMAINDER OF THE VESSEL. DESPITE IMMEDIATE PRESSURE PROXIMAL AND DISTAL TO THE TEAR THE PATIENT RAPIDLY EXSANGUINATED AND ARRESTED. CHEST COMPRESSIONS WERE INITIATED, AND THE INFRARENAL AORTA WAS CROSS-CLAMPED TO CONTROL BLEEDING. SUCCESSFUL CARDIOVERSION WAS ACHIEVED AFTER 3 SUCCESSIVE SHOCKS WITH INCREASING ENERGY, AND NORMAL SINUS RHYTHM WAS REESTABLISHED. ONCE THE PATIENT WAS BACK TO A NORMAL RHYTHM AND STABILIZED, THE ILIAC VEIN WAS LIGATED PROXIMALLY AND DISTALLY TO THE TEAR. TOTAL BLOOD LOSS WAS APPROXIMATELY 5 LITERS REQUIRING TRANSFUSION OF 20 UNITS OF PACKED RED BLOOD CELLS, WITH 10 UNITS EACH OF PLATELETS AND FRESH FROZEN PLASMA. GIVEN THE EVENTS THAT HAD OCCURRED DURING THE APPROACH, THE NEUROSURGICAL PORTION OF THE PROCEDURE WAS ABORTED. THE PATIENT'S PUPILS WERE FIXED AND DILATED FOR 12 HOURS POSTOPERATIVELY WITH NO SIGNS OF BRAINSTEM FUNCTION. A HYPOTHERMIA PROTOCOL WAS INITIATED 3 HOURS AFTER CARDIAC ARREST, AND BY THE SECOND POSTOPERATIVE DAY THE PATIENT WAS EXTUBATED WITH GREATLY IMPROVED MENTAL STATUS. HE WALKED OUT OF THE HOSPITAL ON THE 8TH POSTOPERATIVE DAY AT NEUROLOGICAL BASELINE. HIS POSTOPERATIVE RECOVERY WAS COMPLICATED BY A PERSISTENT LEFT RETROPERITONEAL INFECTED HEMATOMA MEASURING 12.4 CM ON CT. THE INFECTED HEMATOMA WAS TREATED SUCCESSFULLY WITH A PELVIC DRAINAGE CATHETER AND CONSECUTIVE 4-WEEK COURSES OF NAFCILLIN FOLLOWED BY AMOXICILLIN. THE PATIENT RETURNED TO THE CLINIC FOR FOLLOW-UP AT 6 MONTHS IN GOOD HEALTH SEEKING FURTHER TREATMENT FOR HIS PRIMARY COMPLAINT OF NEUROGENIC CLAUDICATION THAT LIMITED HIS WALKING. HIS ONLY COMPLAINT RELATED TO THE EVENTS THAT HAD OCCURRED WAS THAT HE NOW HAD 1+ EDEMA IN HIS LEFT LOWER EXTREMITY GREATER THAN THE RIGHT, FOR WHICH HE WAS CONTINUING TO BE FOLLOWED BY THE VASCULAR SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203137 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 00063 YR Required Intervention