BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFERIOR END PLATE LARGE-STERILE

    MDR report key: 2980788 · Received February 27, 2013

    Report

    Report Number
    2530088-2013-00224
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    January 29, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE, DOB PROVIDED. PRODUCT CLASSIFICATION CODE PROVIDED. EVENT DESCRIPTION UPDATED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE PRODUCT EVENT EVALUATION WAS CONDUCTED AND REPORTED: THE RISK ANALYSIS WAS REVIEWED FOR PRODISC-L. HAZARD 1.3 DESCRIBES IMPLANT SUBSIDENCE AS A POTENTIAL HAZARD LEADING TO POTENTIAL HARMS OF COULD CAUSE PAIN AND/OR PATIENT INJURY (I.E. NEUROLOGICAL DEFICIT) AND REQUIRE REOPERATION WITH SEVERITY 4 (MAJOR) AND OCCURRENCE 2 (UNLIKELY). CURRENT DESIGN CONTROLS INCLUDE: ENDPLATE FOOTPRINTS DESIGNED TO PROVIDE MAXIMUM VERTEBRAL ENDPLATE COVERAGE; SURGEON TRAINING FOR APPROPRIATE SIZING (NOTE THAT SYNTHES REQUIRES ALL SURGEONS COMPLETE COMPREHENSIVE SURGEON TRAINING PRIOR TO USING THE PRODUCT. THIS SURGEON TRAINING INVOLVES ONE DAY TRAINING BY EXPERT FACULTY AND INCLUDES HANDS-ON INSTRUCTION OF IMPLANTATION OF THE PRODISC-L DEVICE USING CADAVERIC MODELS); PATIENT SELECTION AND INSTRUCTIONS FOR USE (OSTEOPOROSIS, OSTEOPENIA, OSTEOMALACIA ARE CONTRAINDICATIONS);TECHNIQUE GUIDE WARNS AGAINST EXCESSIVE BONY REMODELING AND SUBSIDENCE IS DETECTABLE ON POST-OPERATIVE IMAGING. THE HAZARD 3.1 ALSO CAPTURED THE POTENTIAL DESIGN-RELATED CAUSES FOR PATIENT INFECTION RESULTING FROM INSUFFICIENT STERILIZATION AND/OR PACKAGING. HOWEVER, INFECTION IS AN INHERENT RISK OF ALL SURGICAL PROCEDURES, OFTEN ARISING FROM A FAILURE TO FOLLOW PROPER ASEPTIC TECHNIQUE OR MAINTAIN THE STERILE BARRIER. THE LISTED SEVERITY LEVELS AND OCCURRENCE RATES FOR THESE ITEMS CAPTURED ON THE RISK ANALYSIS ARE REPRESENTATIVE OF THIS CASE AND THE COMPLAINT HISTORY TO DATE. THE SIZES OFFERED IN THE SYSTEM ARE APPROPRIATE AS SPECIFIED IN THE PEER-REVIEWED PUBLICATIONS . THE SURGICAL TECHNIQUE AND SURGEON/CONSULTANT TRAININGS ALL STRESS THE IMPORTANCE OF PROPER PATIENT SELECTION AND IMPLANT SIZE SELECTION FOR A GIVEN PATIENT¿S ANATOMY. PREVENTATIVE MEASURES WERE EVALUATED AND FOUND TO BE APPROPRIATE. A JOURNAL REVIEW WAS CONDUCTED TO EVALUATE ARTICLES WITH RELEVANCE TO THE CURRENT COMPLAINT. ONLY ONE DOCUMENTED CASE STUDY ASSOCIATED WITH THE IDE STUDY REPORTS A DEVICE REMOVAL RELATED TO A LATE ABSCESS AND INFECTION 8 MONTHS POST-OP. SEVERAL STUDIES REPORT SUBSIDENCE AS A POTENTIAL COMPLICATION OF LUMBAR DISC REPLACEMENT SURGERY. IN SOME CASES, THE AUTHORS LINK SUBSIDENCE TO PROSTHESIS SIZE (E.G. PROSTHESIS ENDPLATES TOO SMALL). IN SOME CASES, THE AUTHORS LINK SUBSIDENCE TO BONE QUALITY (E.G. BONE DENSITY T-SCORE LESS THAN -1.76. PRODISC-L IS CONTRA-INDICATED FOR PATIENTS WITH A T-SCORE LESS THAN-1.0), INCLUDING UNRECOGNIZED OSTEOPENIA PRE-OPERATIVELY. FOLLOWING THE EVALUATION, THE ROOT CAUSE OF THE INFECTION OR IMPLANT SUBSIDENCE COULD NOT BE DEFINITIVELY DETERMINED. INFECTION IS AN INHERENT RISK IN ALL SURGICAL PROCEDURES, AND MOST LIKELY INVOLVES SOME FAILURE TO FOLLOW IN ASEPTIC TECHNIQUE. POTENTIAL CAUSES FOR THE SUBSIDENCE INDICATED IN THE LITERATURE COULD INCLUDE POOR BONE DENSITY (OSTEOPENIA OR OSTEOPOROSIS), ENDPLATE SIZING, AND ENDPLATE MORPHOLOGY AND PREPARATION.

    Description of Event or Problem · 1

    INITIAL EVENT DESCRIPTION - PATIENT WAS IMPLANTED WITH PRODISC-L AT L4-L5 ON AN UNKNOWN DATE. APPROXIMATELY 3-4 MONTHS POST IMPLANT THE PATIENT PRESENTED WITH FLU-LIKE SYMPTOMS AND A POSSIBLE INFECTION. A CT SCAN TAKEN ON (B)(6) 2013 REVEALED THE PRODISC-L HAD SUBSIDED INTO THE END PLATES. THE PATIENT WAS TAKEN TO THE OR THAT DAY FOR REMOVAL OF THE PRODISC-L AND REVISION TO FRA AND SCREWS. ADDITIONAL, UPDATED INFORMATION - FOLLOW UP INFORMATION FROM THE PHYSICIAN ASSISTANT WAS RECEIVED ON (B)(6) 2013. IT WAS REPORTED THAT ONE WEEK AFTER THE INITIAL SURGERY, THE PATIENT WAS COMPLAINING OF SEVERE PAIN RATED AS A 10 OUT OF SCALE OF 10. A MYELOGRAM PERFORMED PRIOR TO THE REVISION SURGERY REVEALED THE DEVICE WAS SUBSIDING ALONG WITH SIGNS OF INFECTION AND FLUID COLLECTION IN THE EPIDURAL SPACE. THE ORIGINAL HARDWARE IMPLANTED BY A DIFFERENT SURGEON WAS REMOVED AND AN FRA GRAFT WAS LATERALLY IMPLANTED. THE SURGEON ALSO PERFORMED A POSTERIOR FUSION AND A WASHOUT INCISION AND DEBRIDEMENT. THE PATIENTS PAIN LEVEL AS OF (B)(6) 2013 WAS REPORTED TO HAVE IMPROVED SIGNIFICANTLY RATING A 3-4 OUT OF A SCALE OF 10. THIS REPORT IS #3 OF 3 FOR THE SAME EVENT.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH PRODISC-L AT L4-L5 ON AN UNKNOWN DATE. APPROXIMATELY 3-4 MONTHS POST IMPLANT THE PATIENT PRESENTED WITH FLU-LIKE SYMPTOMS AND A POSSIBLE INFECTION. A CT SCAN TAKEN ON (B)(6) 2013 REVEALED THE PRODISC-L HAD SUBSIDED INTO THE END PLATES. THE PATIENT WAS TAKEN TO THE OR THAT DAY FOR REMOVAL OF THE PRODISC-L AND REVISION TO FRA AND SCREWS. THIS REPORT IS #3 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84923 INFERIOR END PLATE LARGE-STERILE PRODISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention