BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 90MM

    MDR report key: 19725822 · Received July 11, 2024

    Report

    Report Number
    1526439-2024-01802
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 14, 2024
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034265742
    PMA / PMN Number
    K111571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. E1: INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE H3, H6: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H4, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY REVIEW (DHR): A REVIEW OF THE RECEIVING INSPECTION (RI) FOR VIPER TI SAI POLY 8X90MM, WAS CONDUCTED IDENTIFYING THAT LOT NUMBER TBAKCD AS RELEASED IN ONE BATCH. ¿ BATCH1: LOT QTY OF 305 UNITS ARE RELEASED ON AUG 04, 2022 WITH NO DISCREPANCIES. SUPPLIER: TOMZ CORP. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. CORRECTED DATA: D4 (UDI) 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

    IT WAS REPORTED THAT THIS WAS A TIRSF (S2) FOR PELVIC FRACTURE ON (B)(6) 2024. IN THE SURGERY, THE SURGEON INSERTED THE S2AI IN THE LEFT AND RIGHT AND ATTEMPTED ROD-SET SCREW FUSION. AFTER THE SET SCREW WAS INSERTED, THE SET SCREW AND THE HEAD OF THE SCREW WAS DAMAGED WHEN THE SET SCREW WAS REMOVED DUE TO FAILURE TO APPLY FINAL TORQUE. SINCE FASTENING BECAME DIFFICULT, A NEW SCREW OF THE SAME SIZE WAS REINSERTED TO COMPLETE THE ROD SET SCREW FUSION. SOME BURRS FELL INTO THE BODY, BUT ALL WERE REMOVED AND FLUOROSCOPY WAS USED TO CONFIRM THAT NO DEBRIS REMAINED IN THE BODY. AFTER THOROUGH CLEANING, THE WOUND WAS CLOSED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. PATIENT WAS LISTED AS STABLE. THIS REPORT IS FOR ONE VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243151 VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 90MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDOS INTERNATIONAL SàRL CH TBAKCD 10705034265742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown