BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER2 STRAIGHT ROD480MM, COCR

    MDR report key: 3821346 · Received May 20, 2014

    Report

    Report Number
    1526439-2014-11519
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    April 29, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK090648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    TWO FRAGMENTS OF A VIPER2 STRAIGHT ROD480MM, COCR [PRODUCT CODE: 1967-89-480, LOT NO: UNKNOWN] WERE RETURNED FOR EVALUATION. THE TWO SAMPLES RETURNED SHOW WEAR ON THE SURFACE, INDICATING THAT THEY WERE USED IN A PATIENT. NO BLACK MATERIAL COULD BE FOUND ON THE SURFACE OF THE RODS, HOWEVER THAT MAY HAVE BEEN REMOVED DURING THE STERILIZATION PROCESS. SCANNING ELECTRON MICROSCOPY (SEM) WAS PERFORMED ON FRACTURED SURFACE A TO FACILITATE A MORE DETAILED INVESTIGATION OF THE FRACTURE CHARACTERISTICS THE ROD. THE FRACTURED SURFACE EXHIBITS EVIDENCE OF FATIGUE STRIATIONS THAT EXTEND UP FROM THE CRACK INITIATION SITE TOWARDS FINAL FRACTURE. AREAS CAN BE SEEN WITH TYPICAL DAMAGE THAT OCCURS WHEN THE TWO FRACTURED COMPONENTS RUB TOGETHER REPEATEDLY POST-SEPARATION. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A DEVICE HISTORY RECORD REVIEW FOR THE VIPER2 STRAIGHT ROD480MM, COCR [PRODUCT CODE: 1967-89-480, LOT NO: UNKNOWN] COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER IS KNOWN. A 12 MONTH COMPLAINT TREND ANALYSIS FOR THE VIPER2 STRAIGHT ROD480MM, COCR [PRODUCT CODE: 1967-89-480, LOT NO: UNKNOWN] BREAKING POST-OP WAS CONDUCTED ON THE PRODUCT CODE. NO SYSTEMIC TREND RESULTING IN FURTHER ACTION WAS IDENTIFIED. THE ROOT CAUSE FOR THE RODS AND SCREW BREAKING CANNOT BE POSITIVELY IDENTIFIED. HOWEVER, THE FATIGUE NATURE OF THE FAILURE CAN BE INDICATIVE OF MOTION AT THE LEVEL DUE TO NON-UNION. SMOKING IS A DRUG KNOWN TO NEGATIVELY AFFECT BONY HEALING AND AS SUCH IS CONSIDERED CONTRAINDICATED PER THE IFU-0902-90-015 REV T. THE COMBINATION OF THE FATIGUE STRIATIONS AND SMOKING MAY INDICATE THE ROOT CAUSE AS FATIGUE DUE TO MOTION IN THE SEGMENT OVER TIME. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS REQUIRED AT THIS POINT AS THERE HAS BEEN NO ISSUES IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE, AND THERE HAVE BEEN NO SYSTEMATIC TREND. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    THE PATIENT HAD PREVIOUSLY EXPERIENCED ROD BREAKAGE BILATERALLY AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2012. THE EVENT WAS REPORTED ON MFG MEDWATCH REPORT NO. 1526439-2012-00194. THE PATIENT HAS A T4-PELVIC CONSTRUCT WITH MULTIPLE LEVELS OF INTERBODY (CONCORDE BULLET). ON (B)(6) 2012, THE SURGEON PERFORMED ANOTHER RE-OPERATION BECAUSE TWO VIPER2 RODS BROKE AT ANOTHER LEVEL (APPROXIMATELY L2-3 BILATERALLY. THE PATIENT IS REPORTED TO BE A HEAVY SMOKER AND STATES THAT SHE BROKE THE RODS BOTH TIMES WHILE BENDING OVER AND PICKING UP OBJECTS. ON THE FIRST OCCASION IT WAS HEAVY BOXES AND THE MOST RECENT IT WAS HER GRANDCHILD. WHEN EXPLANTED, THE RODS HAD A HEAVY COATING OF BLACK MATERIAL OF UNKNOWN ORIGIN ON THEM. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD ADULT SCOLIOSIS/DEFORMITY AND HAD ALSO SHEARED A 7.0MM EXPEDIUM TI SCREW FOR WHICH THE SCREW HEAD HAD SHEARED OFF FROM THE DEVICE. THE SCREW SHAFT WAS LEFT IN THE PATIENT. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE TWO VIPER2 RODS AND ONE EXPEDIUM SCREW THAT ARE REPORTED TO HAVE BROKEN: 1528439-2014-11519, 1526439-2014-11520, 1526439-2014-11521.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300176 VIPER2 STRAIGHT ROD480MM, COCR ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONCORDE BULLET CAGES