BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO-P VA IMPLANT 8MM HEIGHT LORDOTIC-STERILE

    MDR report key: 7014768 · Received November 9, 2017

    Report

    Report Number
    1000562954-2017-10245
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 16, 2017
    Report Date
    October 16, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE, ARTICLE 04.647.128S LOT L143005. THE VISUAL INSPECTION OF THE RETURNED ZERO-P VA CAGE HAS SHOWN NO OBVIOUS DAMAGES. THE DEVICE HISTORY RECORD WAS RESEARCHED, NO ABNORMAL FINDINGS WERE IDENTIFIED. THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT INFORMATION WAS FORWARDED TO THE RESPONSIBLE SUSTAINING ENGINEER FOR A STATEMENT. BASED ON COMPLAINT DESCRIPTION (B)(4) THE SURGEON DID NOT FOLLOW THE ZERO-P VA SURGICAL TECHNIQUE GUIDE. THREE POINTS WHERE IDENTIFIED THAT SURGEON DID NOT FOLLOW THE SURGICAL GUIDANCE. USE OF THE PACKING BLOCK TO PACK ZERO-P VA WITH AUTOLOGOUS BONE OR BONE GRAFT SUBSTITUTE. USE THE CANCELLOUS BONE IMPACTOR TO FIRMLY PACK THE GRAFT MATERIAL INTO THE IMPLANT CAVITY. INSTEAD OF FOLLOWING THIS GUIDANCE THE SURGEON USED HIS HANDS TO PACK THE GRAFT. BY NOT USING THIS PACKING TECHNIQUE, THE BONE GRAFT WON¿T BE PACKED WITH THE INTENDED DENSITY INTO THE CAVITIES OF THE SPACER. USAGE OF THE PACKING BLOCK ENSURES THAT NO BONE CEMENT IS MISPLACED INTO THE SCREW HOLES, WHICH WOULD POTENTIALLY RESULT INTO BLOCKING OF THE SCREW ANGLE AND/OR MOVEMENT. DO THE IMPLANT INSERTION WITH ONE OF THE RECOMMENDED INSTRUMENTS (INSERTION DEVICE OR IMPACTOR WITH IMPLANT HOLDER, IT IS CLEARLY NOT RECOMMENDED TO DO THIS BY HANDS OR USING NON-ZERO-P VA SPECIFIC INSTRUMENTS. THE SURGEON USED HIS HANDS AND A NON-SPECIFIED INSTRUMENT TO HOLD IT. USING HIS HANDS RESULTED INTO MISPLACEMENT OF CEMENT INTO THE SCREW HOLES LEADING TO MENTIONED FUNCTIONAL SCREW ISSUES. TWO OPTIONS ARE GIVEN BY THE INSTRUCTION TO PLACE THE SCREWS. USE OF AWL AND SELF-DRILLING SCREWS. USE OF DRILL GUIDE. THE SURGEON DECIDED TO USE SELF-DRILLING SCREWS (OPTION A) WITHOUT UTILIZING THE AWL AS CLEARLY RECOMMENDED IN THE TECHNIQUE. THE AWL IS NECESSARY TO INSERT THE SCREW IN THE CORRECT ANGLE. NOT DOING THIS WILL LEAD INTO A WRONG POSITIONED AND A HIGH POTENTIAL OF A POORLY FIXATED IMPLANT. THE SURGEON DID NOT FOLLOW THE DESCRIBED STEPS IN THE SURGICAL TECHNIQUE, AS DESCRIBED BEFORE. THIS RESULTED INTO A BREAKUP OF THE PROCEDURE. THE PROBLEMS TO REMOVE THE SCREW AND THE IMPLANT WITH THE REMOVAL TOOL ARE VERY LIKELY CAUSED BY THE NON-COMPLIANT STEPS THE SURGEON DID BEFORE. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.647.128S, LOT# L143005. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: SEP 23, 2016. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. (B)(6). (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS REQUESTED. 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

    ADDITIONAL CONCOMITANT DEVICE REPORTED: CERVICAL SPINE SCREW (PART# 04.647.834, LOT# 9722875, QUANTITY (B)(4)).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING ZERO-P VA SURGERY, ONE OF THE SCREW DIDN´T GET INTO THE BONE, MORE IN THE EXTRACTED DISC AREA. THE SURGEON DIDN´T FOLLOW THE RECOMMENDATIONS IN THE TECHNIQUE GUIDE OR THE SALES REP INSTRUCTIONS. THE CORRECT IMPLANT-HOLDER, OR THE IMPLANT PINCETT WERE USED, ANOTHER KIND OF PINCETT WAS USED. THE SURGEON USED AND HIS FINGERS TO PLACE THE IMPLANT IN BETWEEN THE VERTEBRAS, IN ADDITION, HE FILLED THE IMPLANT WITH BONE MATERIA USING HIS FINGERS WHILE PUTTING BONE MATERIA IN THE SCREW HOLES. THE SALES REP EXPRESSED TO HIM THAT THERE WERE SEVERAL REASONS TO USE THE IMPLANT HOLDER AND IT¿S NOT RECOMMENDED WITH BONE MATERIA IN THE SCREW HOLES. IT WAS REPORTED THAT THE SURGEON SAID, ¿HE WANTS TO DO IT HIS WAY.¿ THE SURGEON REFUSED TO USE THE DRILL OR THE OWL, THE SURGEON ALLEGED THAT SINCE THE SCREWS ARE SELF-DRILLING AND THE BONE IS SOFT, HE'S DECIDING NOT TO DRILL. THE SALES REP COMMUNICATED TO THE SURGEON AGAIN, THAT THERE IS A RISK THAT THE SCREW WILL FAIL TO PENETRATE THE ENDPLATE OF THE VERTEBRA IF HE DOESN¿T DRILL OR OWL. THE SCREW THAT HE WANTED TO TAKE IT OUT, WAS MISPLACE. THE SURGEON TRIED FIRST WITH THE SCREW REMOVAL BLADE AND THE SCREWDRIVER, HOWEVER, HE WAS NOT ABLE TO GET THE SCREW OUT. HE THEN TRIED THE SCREW REMOVAL SCREW DRIVER, BUT THE TIP OF THE INNER SHAFT FOR SCREW REMOVAL SCREWDRIVER BROKE OF, AND GOT STUCK IN ONE OF THE SCREWS. THE SALES REP RECOMMENDATIONS WAS NOT FOLLOWED DURING THIS PROCEDURE EITHER. HOWEVER, THE SURGEON DID MANAGE TO GET THE WHOLE IMPLANT WITH THE SCREWS OUT. ANOTHER IMPLANT INSTEAD, A COMPETITOR PRODUCT, WAS PUT IN - THIS WAS THE STANDARD PROCEDURE FOR THE SURGEON. THE SURGERY WAS DELAYED 20-25 MINUTES. FRAGMENTS WERE GENERATED AND REMOVED, SOME EASILY, WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO IMPACT ON THE PATIENT BECAUSE OF THE SURGEON NOT FOLLOWING THE RECOMMENDATIONS GIVEN TO HIM FROM THE SALES REP. THIS COMPLAINT INVOLVES ONE PART CONCOMITANT PARTS REPORTED: 1X DRILL BIT, 1X AWL, 1X IMPLANT, 1X SCREW REMOVAL BLADE, 1X SCREWDRIVER, 1X IMPLANT HOLDER, 1X BONE MATERIAL, 1X PINCETT. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795757 ZERO-P VA IMPLANT 8MM HEIGHT LORDOTIC-STERILE INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE SYNTHES MEZZOVICO L143005

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention