BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P IMPLANT 5MM HEIGHT CONVEX-STERILE

    MDR report key: 7778232 · Received August 13, 2018

    Report

    Report Number
    8030965-2018-55682
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 20, 2018
    Report Date
    July 25, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    OVE
    UDI-DI
    07611819934252
    PMA / PMN Number
    K072981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    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. PART: 04.617.135S; LOT: L833913; MANUFACTURING SITE: MEZZOVICO; RELEASE TO WAREHOUSE DATE: APRIL 13, 2018; EXPIRY DATE: APRIL 01, 2028. THE DEVICE HISTORY RECORD SHOWS THIS LOT 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. COMPONENT PART: 60023749; LOT: L8066857; MANUFACTURING SITE: HÄGENDORF; RELEASE TO WAREHOUSE DATE: MARCH 15, 2018. THE DEVICE HISTORY RECORD SHOWS THIS LOT 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. COMPONENT PART: 60022228; LOT: 9657487; MANUFACTURING SITE: HÄGENDORF; RELEASE TO WAREHOUSE DATE: OCTOBER 13, 2015. THE DEVICE HISTORY RECORD SHOWS THIS LOT 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. INVESTIGATION SITE: CQ ZUCHWIL; SELECTED FLOWS 2 & 3: DEVICE INTERACTION/FUNCTIONAL & DAMAGE / VISUAL: VISUAL INVESTIGATION: THE PEEK SPACER AND THE TITANIUM INTERBODY PLATE WERE SEPARATED UPON RECEIPT. THE PEEK SPACER IS NOT BROKEN BUT SHOWS DAMAGE FROM A MISALIGNED DRILL ATTEMPT. THE TITANIUM INTERBODY PLATE SHOWS DAMAGE AT BOTH OUTSIDE THREADED LOCKING BORES. FUNCTIONAL TEST: A FUNCTIONAL TEST CANNOT BE CONDUCTED BECAUSE OF THE DAMAGE CAUSED DURING USE. THE CONNECTING FEATURES ON THE PEEK SPACER ARE PARTIALLY DEFORMED AND DAMAGED, THEREFORE THE SEPARATED COMPONENTS CANNOT BE ASSEMBLED TOGETHER ANYMORE. DIMENSIONAL INSPECTION: BECAUSE OF THE EXISTING USE-RELATED DAMAGE ON BOTH COMPONENTS, A DIMENSIONAL INSPECTION CANNOT BE CONDUCTED AND IS NOT REQUIRED PER SELECTED INVESTIGATION FLOW BROKEN. DOCUMENT/SPECIFICATION REVIEW: THE CAUSE OF THE COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE-RELATED BREAKAGE/DAMAGE ON THE DEVICE, THEREFORE NO DOCUMENT/SPECIFICATION REVIEW IS REQUIRED PER SELECTED INVESTIGATION FLOW BROKEN. CONCLUSION: THE PEEK SPACER AND THE TITANIUM INTERBODY PLATE ARE SEPARATED AND BOTH COMPONENTS SHOW POST-MANUFACTURING DAMAGE CAUSED DURING USE AND THE COMPLAINT THEREFORE IS CONFIRMED. THE PEEK SPACER SHOWS DAMAGE FROM A MISALIGNED DRILL ATTEMPT. THE TITANIUM INTERBODY PLATE SHOWS DAMAGE AT BOTH OUTSIDE THREADED LOCKING BORES, THE ANODIZED COLOR HAS DISAPPEARED IN DAMAGED OR WORN AREAS. ALL DAMAGES WERE CAUSED POST MANUFACTURING AND PRESENT THE APPLICATION OF INCORRECT SURGICAL ALIGNMENT PROCEDURES WHILE USE. THE ZERO-P AND ZERO-P CHRONOS ZERO PROFILE ANTERIOR CERVICAL INTERBODY FUSION DEVICE SURGICAL TECHNIQUE DESCRIBES THE CORRECT ANGULATIONS FOR THE DRILL BORES FOR SCREWS ARE 40° +/- 5° IN THE CAUDAL OR CRANIAL DIRECTION. THE MEDIAL SCREWS POINT 2.5° LATERALLY AND THE LATERAL SCREWS POINT 2.5° MEDIALLY. VISUALLY, THERE SEEMS TO BE NO PROBLEM OTHER THAN THE DAMAGE CAUSED BY THE FAILURE TO FOLLOW THE SURGICAL TECHNIQUE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    LOT AND EXPIRATION DATE, THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 IS UNKNOWN. LOT NUMBER IS UNKNOWN. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER EMAIL ADDRESS IS UNKNOWN. REPORTER IS A SYNTHES EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN ANTERIOR CERVICAL DISCECTOMY ON (B)(6) 2018, THE ZERO-P IMPLANT (PEEK) BROKE WHILE THE SURGEON WAS INSERTING IT INTO THE PATIENT¿S BODY. THE SURGEON REMOVED THE BROKEN IMPLANT AND REPLACED IT WITH A NEW ONE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THREE (3) MINUTE DELAY. THERE WERE NO REPORTED PATIENT CONSEQUENCES. THIS REPORT IS FOR A ZERO-P IMPLANT 5MM HEIGHT CONVEX-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617895 ZERO-P IMPLANT 5MM HEIGHT CONVEX-STERILE INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL OVE OBERDORF SYNTHES PRODUKTIONS GMBH L833913 07611819934252

    Patients

    Seq Age Sex Outcome Treatment
    1