BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE

    MDR report key: 7923380 · Received October 1, 2018

    Report

    Report Number
    8030965-2018-56869
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    January 1, 2018
    Report Date
    September 5, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    OVE
    UDI-DI
    07611819405271
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART: 04.647.127S, LOT: L891400: MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 17. MAY. 2018, EXPIRY DATE: 01. MAY 2028: THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 8 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 · 0

    PRODUCT INVESTIGATION WAS COMPLETED. THE DEVICE WAS FOUND IN A GOOD CONDITION AND WAS RECEIVED IN ASSEMBLED CONDITION. THERE ARE SOME SCRATCHES VISIBLE AT THE METALLIC PART. THE RETURNED DEPTH GAUGE WAS TESTED AT CUSTOMER QUALITY DEPARTMENT AND THE COMPLAINT CONDITION COULD NOT BE CONFIRMED. THE FUNCTIONALITY OF THE DEVICE WAS GIVEN, AS THE PARTS COULD BE ASSEMBLED/ DISASSEMBLED AS PER DESIGN INTENDED. THE INVESTIGATION HAS SHOWN THAT THE COMPLAINT CONDITION IS UNCONFIRMED. UNFORTUNATELY THE EXACT ROOT CAUSE COULD NOT BE DETERMINED AS NO DETAILED CLINICAL INFORMATION AVAILABLE. ADDITIONALLY, THE COMPLAINED MALFUNCTION COULD NOT BE REPRODUCE AS DEVICE PASSED THE REQUIRED FUNCTIONAL CHECK SUCCESSFULLY. BASED ON THIS RESULT WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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

    EVENT YEAR REPORTED AS 2018; EXACT DATE IS UNKNOWN. DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, DURING CAGE POSITIONING, THE TWO COMPONENTS DETACHED. DESPITE THE REASSEMBLY THE SAME COMPONENTS DIDN'T REMAIN UNITED. THE ISSUE WAS SOLVED USING ANOTHER CAGE, HAVING THE SAME SIZE AND CHARACTERISTICS. THERE WAS NO PATIENT HARM REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) ZERO-P VA IMPLANT 7MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763914 ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE OBERDORF SYNTHES PRODUKTIONS GMBH L891400 07611819405271

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR