BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSE CORRECTION KEY

    MDR report key: 9720439 · Received February 18, 2020

    Report

    Report Number
    1526439-2020-00558
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 9, 2020
    Report Date
    January 9, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034466132
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. H11: B1, B5, H1: THE INITIAL REPORT WAS REVIEWED AND FOUND TO BE A DUPLICATE OF A REPORT ON (B)(4). ALL INFORMATION FOR THIS DEVICE IS CAPTURED ON REPORT MANUFACTURER REPORT NUMBER 1526439-2020-00535. 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

    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. VISUAL INSPECTION: THE VERSE CORRECTION KEY (PART # 199721000/ LOT # 173892) WAS RECEIVED AT US CQ. THE FINAL TWO DISTAL 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 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 HISTORY THE DHR OF PRODUCT CODE 199721000, LOT 173892, WAS REVIEWED AND NO NON-CONFORMANCES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON DECEMBER 15TH, 2017. QTY. (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 · 0

    THE INITIAL REPORT WAS REVIEWED AND FOUND TO BE A DUPLICATE OF A REPORT ON (B)(4). ALL INFORMATION FOR THIS DEVICE IS CAPTURED ON REPORT MANUFACTURER REPORT NUMBER 1526439-2020-00535.

    Additional Manufacturer Narrative · 1

    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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS UNDERWENT FOR A SURGERY THEY TAKE THE TRIAL IMPLANT AND BREAK IT UNDER THE UNKNOWN TRAIL. THE SURGERY WAS DELAYED TEN (10) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN OTHER PRODUCTS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 4). UNKNOWN OTHER PRODUCTS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY 4). THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183850 VERSE CORRECTION KEY ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB MEDOS INTERNATIONAL SàRL CH 199721000 173892 10705034466132

    Patients

    Seq Age Sex Outcome Treatment
    1 QUANTITY 4| QUANTITY 4