BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3944249 · Received July 18, 2014

    Report

    Report Number
    2520274-2014-12639
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    May 19, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CHOU, D., LU, D., WEINSTEIN, P., & AMES, C. (2008). ADJACENT-LEVEL VERTEBRAL BODY FRACTURES AFTER EXPANDABLE CAGE RECONSTRUCTION. JOURNAL OF NEUROSURGERY SPINE (8), 584-588. THIS REPORT IS FOR AN UNKNOWN TSLP PLATE, UNKNOWN PART NUMBER AND UNKNOWN LOT NUMBER. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE ¿ADJACENT-LEVEL VERTEBRAL BODY FRACTURES AFTER EXPANDABLE CAGE RECONSTRUCTION.¿ A (B)(6) MALE SUSTAINED AN L-3 COMPRESSION FRACTURE AFTER A MOTOR VEHICLE ACCIDENT. AFTER CONSERVATIVE TREATMENT FOR 10 MONTHS, THE PATIENT CONTINUED TO HAVE BACK PAIN. A CORPECTOMY WAS RECOMMENDED. THE PATIENT UNDERWENT AN ANTERIOR RETROPERITONEAL APPROACH FOR AN L-3 CORPECTOMY. RECONSTRUCTION WAS PERFORMED USING AN EXPANDABLE SYNEX CAGE AND AN ANTERIOR THORACOLUMBAR SPINE LOCKING PLATE SYSTEM (TSLP) PLATE FROM L-2 TO L-4. ARTHRODESIS WAS PERFORMED USING VERTEBRECTOMY BONE. SIX WEEKS LATER AT FOLLOW-UP, THE PATIENT COMPLAINED OF PAIN, AND A LATERAL RADIOGRAPH SHOWED A FRACTURE THROUGH THE L-2 VERTEBRAL BODY. A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED A CORONAL PLANE FRACTURE THROUGH THE L-2 VERTEBRAL BODY. SUBSEQUENTLY, THE PATIENT UNDERWENT ANTERIOR REVISION WITH THE REMOVAL OF THE CAGE, AN L-2 CORPECTOMY, PLACEMENT OF A LARGER EXPANDABLE CAGE, AND POSTERIOR SEGMENTAL STABILIZATION FROM T-12 TO L-5. THERE WAS NO VASCULAR INJURY SECONDARY TO THE FRACTURE. IT WAS THE OPINION OF THE AUTHORS THAT INITIAL EXPERIENCES OF VERTEBRAL BODY REPLACEMENT WITH EXPANDABLE CAGES HAVE YIELDED GOOD RESULTS. AS THE USE OF EXPANDABLE CAGES INCREASES, HOWEVER, COMPLICATIONS ARISE. INSTRUMENTATION FAILURE HAS BEEN REPORTED WITH THE USE OF EXPANDABLE CAGES, AND IN PATIENTS WITH OSTEOPOROSIS, SIGNIFICANT SUBSIDENCE OF THE CAGE (> 5 MM) OCCURS IN AS MANY AS 17%. FRACTURES AT THE L-3 VERTEBRAL BODY ARE COMMON FRACTURES BECAUSE OF ITS LOW COMPRESSION STRENGTH COMPARED WITH OTHER LUMBAR LEVELS. ALSO, THERE IS INCREASED SEGMENTAL MOTION (FLEXION AND EXTENSION) AT THE L3-4 LEVEL COMPARED HIGHER LUMBAR LEVELS. THE COMBINATION OF LOW COMPRESSIVE STRENGTH AND INCREASED SEGMENTAL MOTION LOCATIONS MAY PLACE INCREASED STRESS AT THE L-3 LEVEL. HYPOTHESES OF THE AUTHORS INCLUDED 3 REASONS WHY THE FRACTURE MAY HAVE OCCURRED. THE FIRST REASON IS THE EXPANDABLE NATURE OF CAGES. THE FORCES GENERATED BY CAGES CAN BE SIGNIFICANT, AND THIS FORCE ULTIMATELY MAY RESULT IN FAILURE OF THE ENDPLATE TO RESIST IT. THE SECOND REASON IS THE ACTUAL PLACEMENT OF THE CAGE AGAINST THE ENDPLATE AND/OR SCREW FIXATION ABOVE OR BELOW THE CAGE. BOTH MAY CAUSE STRESS RISERS. THE THIRD REASON IS BONE QUALITY. IT WAS REPORTED THAT NEARLY ALL OF THE PATIENTS MENTIONED IN THE 4 CASE STUDIES HAD SOME COMPONENT OF OSTEOPOROSIS OR OSTEOPENIA, ALTHOUGH IT WAS NOT CONFIRMED THAT THE (B)(6) MALE HAD EITHER CONDITION. THE AUTHORS CONCLUDED THAT EXPANDABLE CAGES CAN CAUSE ADJACENT LEVEL VERTEBRAL BODY FRACTURES. THE MECHANISM FOR THIS TYPE OF FRACTURE IS PROBABLY MULTIFACTORIAL, AND ADDITIONAL STUDIES ARE WARRANTED. THE FAILURE PATTERN IN EXPANDABLE CAGES APPEARS TO BE MORE DESTRUCTIVE THAN THE FAILURE PATTERN OBSERVED WITH NONEXPENDABLE CAGES. CARE SHOULD BE TAKEN TO AVOID AGGRESSIVE EXPANSION, ESPECIALLY IN PATIENTS WITH OSTEOPOROTIC BONES AND IN CASES IN WHICH THE CAGE-TO-ENDPLATE CONTACT IS LESS THAN IDEAL. THIS REPORT IS FOR 1 UNKNOWN TSLP PLATE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422998 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention