BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNESYS LIS, STABILIZING CORD, 100

    MDR report key: 6016851 · Received October 11, 2016

    Report

    Report Number
    0009613350-2016-01257
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 15, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATES: DESCRIBE EVENT OR PROBLEM, BRAND NAME, COMMON DEVICE NAME, MODEL #/LOT #, IMPLANT DATE, DEVICE AVAILABLE FOR EVALUATION?, DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, DEVICE EVALUATED BY MFR?, EVALUATION CODES, ADDITIONAL MFR NARRATIVE. THE MANUFACTURER RECEIVED THE DEVICES FOR INVESTIGATION ON NOVEMBER 22, 2016. THE INVESTIGATION IS PENDING. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION RESULTS HAVE BEEN MADE AVAILABLE. WHERE LOT NUMBERS WERE AVAILABLE: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION : PATIENT HAD DTL AT L4-L5 AND FUSED. PATIENT UNFORTUNATELY FAILED AT THE ADJACENT LEVEL AND NEEDS FUSION AT L3-L4. SURGEON REMOVED SCREWS FROM L5, PUT SCREWS IN AT L3 AND A NEW CORD AND SPACER. REVIEW OF RECEIVED INFORMATION: CLINICAL INFORMATION: IN THE FOLLOWING THE MAIN POINTS OF THE RECEIVED REPORTS ARE SUMMARIZED. MRI EXAM OF THE LUMBAR SPINE WITHOUT CONTRAST DATED (B)(6) 2016 WHICH IS COMPARED TO THE EXAM DATED (B)(6) 2015. ¿THERE IS POSTERIOR FUSION HARDWARE WITH METAL ARTIFACT AT L4-5. THE ANTEROLISTHESIS AT L4 AND L5 IS 8 MM AND UNCHANGED.¿ THERE IS ¿SOME PROGRESSION OF LATERAL RECESS AND CANAL NARROWING AT L3-4 ABOVE THE FUSION.¿ X-RAY EXAM OF THE LUMBAR SPINE DATED (B)(6) 2016 WAS COMPARED TO THE EXAM DATED (B)(6) 2016. AN INCREASED SPONDYLOLISTHESIS OF L3 ON L4 CAN BE SEEN NOW MEASURING APPROXIMATELY 7 MM. THE SPONDYLOLISTHESIS OF L4 ON L5 IS STABLE. THE OPERATIVE REPORT DATED (B)(6) 2016 REPORTS THAT A BILATERAL TRANSFORAMINAL EPIDURAL STEROID INJECTION USING FLUOROSCOPY WAS PERFORMED AT L3-4. THE INDICATION FOR THIS IS A PREVIOUS L4-5 FUSION AND NOW AN L3-4 SPONDYLOLISTHESIS AND SEGMENT FAILURE WITH SYMPTOMS. PHYSICAL THERAPY PROGRESS REPORT DATED (B)(6) 2016: STATED THAT THE PATIENT DEMONSTRATES IMPROVEMENTS BUT STILL COMPLAINS OF PAIN AS WELL AS STIFFNESS AND WOULD BENEFIT TO CONTINUE SKILLED PHYSICAL THERAPY TO ADDRESS DEFICITS AND REACH ALL GOALS. THE CONSULTATION REPORT OF FOLLOW-UP EXAM DATED (B)(6) 2016 SUMMARIZES THAT ON (B)(6) 2013 AN L4-L5 FUSION FOR A GRADE II SPONDYLOLISTHESIS ASSOCIATED WITH SPONDYLOLYSIS WAS PERFORMED. THE FUSION WAS SOLID. PRIOR TO SURGERY THE PATIENT HAD LEFT LOWER EXTREMITY PAIN, FOOT DROP AND NUMBNESS. IN 2015 THE PATIENT DEVELOPED RECURRENT PAIN. SINCE (B)(6) 2016 THE PATIENT HAS BEEN ON DISABILITY BECAUSE OF THE DIFFICULTY OF STANDING ALL DAY AT WORK. IN EARLY APRIL THE PATIENT HAD A FALL. THE IMAGING REVEALED EVIDENCE OF L3-L4 SEGMENTAL FAILURE AND SPONDYLOLISTHESIS GRADE I, FURTHER STENOSIS WAS SEEN AT L3-L4. THE PATIENT IS HABITUATED TO NARCOTIC ANALGESIA. ON (B)(6) 2016 THE PATIENT UNDERWENT A BILATERAL EPIDURAL STEROID INJECTION AT L3-L4. THIS HELPED THE PATIENT. THE PATIENT ALSO HAD PHYSICAL THERAPY. HOWEVER IS NOT FREE OF PAIN. A NEW IMAGING EXAM REVEALED THE SAME FINDINGS CONCERNING L3-L4. THE PATIENT IS INDECISIVE ABOUT THE FURTHER TREATMENT BUT IS CURRENTLY FAVOURING ANOTHER EPIDURAL STEROID INJECTION INSTEAD OF RE-EXPLORATION AND FUSION AT L3-L4. (B)(6). SINCE THE LAST VISIT THE PATIENT GAINED WEIGHT. AN INFORMED CONSENT FOR THE USE OF RETRIEVED IMPLANTS IS AT HAND SIGNED BY THE PATIENT ON (B)(6) 2016. DEVICE ANALYSIS: IT IS UNKNOWN WHY THE PEDICLE SCREW LOCATED AT L4 RIGHT WAS MISSING. DAMAGE IN THE FORM OF MATERIAL REMOVAL COULD BE SEEN ON THE HEADS AND THREADS OF THE PEDICLE SCREWS. THERE WERE REMAINS OF BONE ON THE THREAD AS WELL AS THE CANNULATION OF THE SCREWS. THE SET SCREWS ARE SLIGHTLY DAMAGED ON THE INTERNAL HEXAGON AS WELL AS THE THREAD. ON THE CORD THE FIXATION AREAS WHERE THE SCREW HEADS WERE LOCATED WERE CLEARLY RECOGNIZABLE. THE FIXATION AREAS WERE FLATTENED. AT THEIR ENDS AS WELL AS AT THE ZONE WHICH WAS IN CONTACT WITH THE TIP OF THE SET SCREW SINGLE BUNDLES OF FIBRES STICK OUT. AT ONE OF THE FIXATION AREAS OF THE RIGHT CORD THERE SEEMS TO BE A CUT IN THIS AREA LEADING TO PRONOUNCED DAMAGE. BOTH CORDS SHOWED ONE CUT END WHEREBY THAT OF THE RIGHT CORD IS FRAYED. OTHERWISE THE CORDS APPEAR TO BE INCONSPICUOUS. THE SPACERS PRESENT SLIGHT CURVATURE IN LONGITUDINAL DIRECTION. ON THE LATERAL AREA OF BOTH SPACERS LARGER DAMAGE IN THE FORM OF DEEPER SCRATCHES CAN BE SEEN WHICH MOST LIKELY OCCURRED DUE TO THE REVISION SURGERY. FURTHER, THERE ARE SOME WORN AREAS WHICH COULD BE ATTRIBUTED TO ABRASION DUE TO THEIR FINE WAVELIKE RIBBED STRUCTURE IDENTIFIABLE WITH THE MICROSCOPE. THE RIGHT SPACER EXHIBITS A WORN AREA WITH A DEPTH OF1 -2 MM. INDENTATIONS FROM THE SCREW HEADS ON BOTH FRONT SURFACES INCLUDING AT LEAST ON ONE FRONT SURFACE MARKS FROM THE THREAD OF THE SET SCREWS IN THE U-SHAPED OPENING OF THE SCREW HEAD COULD BE DETECTED. WITHIN THE INDENTATIONS THERE ARE OTHER SMALLER INDENTATIONS OF IRREGULAR GEOMETRY WHICH POSSIBLY MAY HAVE DERIVED FROM TISSUE PARTICLES THAT GOT CLAMPED BETWEEN SPACER AND SCREW HEAD. ADDITIONALLY, THERE WERE SLIGHT ABRASION ZONES ON ONE FRONT SURFACE OF EACH SPACER. INDENTATIONS OF THE CORD STRUCTURE INSIDE THE ENCLOSED CHANNEL COULD BE RECOGNIZED AS WELL ON BOTH SPACERS. CONCLUSION: THE PATIENT UNDERWENT A FUSION AT L4-L5 FOR A GRADE II SPONDYLOLISTHESIS ASSOCIATED WITH SPONDYLOLYSIS ON (B)(6) 2013. IN 2015 THE PATIENT DEVELOPED RECURRENT PAIN AND WAS DISABLE TO WORK SINCE (B)(6) 2016. THE IMAGING REVEALED EVIDENCE OF L3-L4 SEGMENTAL FAILURE AND SPONDYLOLISTHESIS GRADE I, FURTHER STENOSIS WAS SEEN AT L3-L4. ON (B)(6) 2016 A REVISION SURGERY WAS PERFORMED WHERE THE CURRENT DYNESYS TL SYSTEM WAS REMOVED AND A NEW SYSTEM PROLONGED TO L3 WAS IMPLANTED. EXCEPT FOR THE RIGHT L4 PEDICLE SCREW ALL PARTS OF THE REVISED DYNESYS SYSTEM WERE RECEIVED FOR INVESTIGATION. IT IS UNKNOWN WHY THE RIGHT L4 PEDICLE SCREW IS MISSING. ALMOST ALL PARTS SHOW SOME DAMAGE, E.G. SCRATCHES OR CUTS, PROBABLY DERIVING FROM THE REVISION SURGERY. ON THE PEDICLE SCREWS REMAINS OF BONE COULD BE FOUND. THE APPEARANCE OF THE CORDS INDICATING FIXATION AREAS THAT WERE IN CONTACT WITH THE SCREWS IS INCONSPICUOUS. INDENTATIONS ON THE SPACERS COULD BE OBSERVED ON THE FRONT SURFACES FROM THE SCREW HEADS AS WELL AS IN THE ENCLOSED CHANNEL FROM THE CORDS. WITHIN THE INDENTATIONS ON THE FRONT SURFACES OF THE SPACER OTHER SMALLER INDENTATIONS OF IRREGULAR GEOMETRY WERE VISIBLE. THESE POSSIBLY MAY HAVE DERIVED FROM TISSUE PARTICLES THAT GOT CLAMPED BETWEEN SPACER AND SCREW HEAD. THE WORN AREAS SEEN ON THE LATERAL SURFACE OF THE SPACERS CAN PROBABLY BE ASCRIBED TO BONE CONTACT. THE SLIGHT ABRASION ZONES ON THE FRONT SURFACE OF THE SPACERS MOST LIKELY ORIGINATED FROM SOME MICRO MOTION BETWEEN SCREW AND SPACER. THE SYSTEM WAS REVISED DUE TO ADJACENT LEVEL FAILURE AND NOT DUE TO A DEVICE FAILURE. THE MACROSCOPICALLY VISIBLE MODIFICATIONS FOUND ON THE PARTS OF THE DEVICE WOULD NOT AFFECT THE PROPER FUNCTIONING OF THE SYSTEM. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED TWO DYNESYS LIS, STABILIZING CORD, 100 ON (B)(6) 2013. IT WAS ALSO REPORTED: "PATIENT HAD A DTC AT L4-L5 AND FUSED. PATIENT UNFORTUNATELY FAILED AT ADJACENT LEVEL AND NEEDS FUSION AT L3-L4. SURGEON REMOVED SCREWS FROM L5 PUT SCREWS IN AT L3 AND A NEW CORD AND SPACER." THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED TWO UNKNOWN DYNESYS CORD SPINE IMPLANTS ON AN UNKNOWN DATE. IT WAS ALSO REPORTED: "PATIENT HAD A DTC AT L4-L5 AND FUSED. PATIENT UNFORTUNATELY FAILED AT ADJACENT LEVEL AND NEEDS FUSION AT L3-L4. SURGEON REMOVED SCREWS FROM L5 PUT SCREWS IN AT L3 AND A NEW CORD AND SPACER." THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2016.

    Description of Event or Problem · 1

    THIS CASE WAS PART OF A CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669389 DYNESYS LIS, STABILIZING CORD, 100 DYNESYS SPINAL SYSTEM NQP ZIMMER GMBH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R