BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P VA IMPLANT 7MM HEIGHT PARALLEL/LARGE-STERILE

    MDR report key: 6630568 · Received June 9, 2017

    Report

    Report Number
    3003875359-2017-10279
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    May 17, 2017
    Report Date
    May 17, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. THE 04.647.217S, LOT NUMBER 8200433, ZERO-P VA IMPLANT 7MM HEIGHT PARALLEL/LARGE-STERILE WAS RETURNED WITH THE INTERBODY PLATE DETACHED FROM THE PEEK SPACER. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT WAS ABLE TO BE REPLICATED AT CUSTOMER QUALITY (CQ). THIS COMPLAINT IS CONFIRMED. DURING VISUAL INSPECTION, IT WAS NOTED THAT THE TWO COMPONENTS ARE NOT DAMAGED; THE RETURNED IMPLANT WAS ABLE TO BE REASSEMBLED. WHEN APPLYING OPPOSITE LOADING TO THE TWO COMPONENTS, THE INTERBODY PLATE DETACHED FROM THE PEEK SPACER. THE 04.647.217 7MM PARALLEL ZERO-P VA IMPLANT IS UTILIZED IN THE ZERO-P VA (ZERO-PROFILE, VARIABLE ANGLE) SYSTEM FOR ANTERIOR CERVICAL INTERBODY FUSIONS (ACIF). THE ZERO-P VA IMPLANT WAS DESIGNED TO HAVE A SEMI-RIGID CONNECTION BETWEEN THE INTERBODY PLATE AND SPACER, ALLOWING THE PLATE TO FUNCTION AS AN ANTERIOR INTERBODY PLATE AND THE SPACER TO FUNCTION AS AN INTERBODY SPACER; THE DESIGN DISASSOCIATES THE STRESSES BETWEEN THE COMPONENTS ALLOWING THEM TO FUNCTION INDEPENDENTLY. IF THE PLATE AND SPACER SEPARATE INTRAOPERATIVELY, THEY MAY BE REASSEMBLED, AS LONG AS BOTH COMPONENTS ARE NOT DAMAGED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. IN ORDER FOR THE PLATE TO SEPARATE FROM THE PEEK SPACER, OPPOSITE LOADING MUST BE APPLIED TO THE TWO COMPONENTS, WHICH CAN OCCUR DURING IMPLANT INSERTION IF PROPER DISTRACTION IS NOT PREVIOUSLY ACHIEVED. ALTERNATIVELY, HOLE PREPARATION AND/OR SCREW INSERTION OUTSIDE OF THE RECOMMENDED SCREW INSERTION RANGE COULD INTRODUCE STRESSES WHICH COULD CONTRIBUTE TO THE COMPLAINT CONDITION. IMPLANT SEPARATION POST-OPERATIVELY IS UNLIKELY BECAUSE, ONCE IMPLANTED, LOADING ON BOTH COMPONENTS WILL OCCUR IN THE SAME DIRECTION. RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. (B)(4). 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED 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 CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 23.JAN.2013. EXPIRY DATE: 31.DEC.2022. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF),DISC LEVEL C5-6, ON (B)(6) 2017 AND WAS IMPLANTED WITH A ZERO-P VARIABLE ANGLE (VA)) IMPLANT AND TWO (2) SCREWS. AS THE SURGEON WENT TO PLACE THE IMPLANT, THE ZERO-P VA PLATE AND SPACER SEPARATED DURING INSERTION. A NEW DEVICE WAS OPENED AND THE SURGEON PROCEEDED WITHOUT ANY FURTHER ISSUES. THERE WAS NO DELAY IN THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT REPORTED AS STABLE. THERE IS 1 DEVICE FOR THIS REPORT. CONCOMITANT DEVICE: UNKNOWN SCREW (ITEM # UNKNOWN, LOT # UNKNOWN, QUANTITY 2 EACH) . THIS REPORT IS 1 OF 1 COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412625 ZERO-P VA IMPLANT 7MM HEIGHT PARALLEL/LARGE-STERILE INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE SYNTHES HAGENDORF 8200433

    Patients

    Seq Age Sex Outcome Treatment
    1