BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSE CORRECTION KEY

    MDR report key: 9706891 · Received February 13, 2020

    Report

    Report Number
    1526439-2020-00534
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    January 20, 2020
    Report Date
    January 23, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034466132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    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. H3, H4, H6: THE DHR OF PRODUCT CODE 199721000, LOT 231425, WAS REVIEWED AND NO NON-CONFORMANCES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON FEBRUARY 4TH, 2019. QTY. (B)(4). REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE VERSE CORRECTION KEY (PART # 199721000/ LOT # 231425) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). THE MOST PROXIMAL THREAD FORMS OF THE DEVICE WERE TORN FROM THE CORE. IT APPEARS THE DEVICE WAS SUBJECT TO EXCESSIVE FORCE AS THE THREAD TIPS WERE DISCOLORED. THE OVERALL COMPLAINT WAS CONFIRMED. DEVICE FAILURE/DEFECT IDENTIFIED? YES; THREADS WERE TORN. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: DRAWING(S) REVIEWED: CURRENT & MANUFACTURED REVISIONS. CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED VERSE CORRECTION KEY AS THE MOST PROXIMAL THREADS WERE TORN FROM THE CORE. ALTHOUGH NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED ITS POSSIBLE THE DEVICE EXPERIENCED UNINTENDED FORCES WHILE IN USE. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DUAL INNIE SET SCREW THREAD WAS SHREDDED AND NOT WORKING PROPERLY. THERE WAS NO REPORTED SURGERY DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. WITHOUT ADDITIONAL INTERVENTION SURGEON WAS REMOVED ALL FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 02 OF 04 OF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168359 VERSE CORRECTION KEY ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB MEDOS INTERNATIONAL SàRL CH 199721000 231425 10705034466132

    Patients

    Seq Age Sex Outcome Treatment
    1