BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 45MM

    MDR report key: 15774786 · Received November 10, 2022

    Report

    Report Number
    1526439-2022-01937
    Event Type
    Injury
    Date Received
    November 10, 2022
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWP
    UDI-DI
    10705034465791
    PMA / PMN Number
    K160904
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: ADDITIONAL PROCODES: OSH, MNH, KWQ, MNI, NKB. 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. 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. A REVIEW OF THE RECEIVING INSPECTION (RI) FOR CORTICAL FIX X-TAB 7X45MM TI WAS CONDUCTED IDENTIFYING THAT LOT NUMBER TBKZM WAS RELEASED IN ONE BATCH. ¿ BATCH1: LOT QTY OF 250 UNITS WERE RELEASED ON (B)(6) 2015 WITH NO DISCREPANCIES. SUPPLIER: DEPUY : TOMZ CORPORATION. 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. 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 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

    DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN SURGERY WAS PERFORMED WITH THE CORTICAL FIX X-TABS AND THE RODS IN QUESTION. A REVISION PROCEDURE WILL BE PERFORMED FOR FUSION EXTENSION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 45MM. THIS IS REPORT 2 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274899 VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 45MM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDOS INTERNATIONAL SàRL CH 186770145 TBKZM 10705034465791

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention CORTICAL FIX X-TAB 7X45MM TI| CORTICAL FIX X-TAB 7X45MM TI| CORTICAL FIX X-TAB 7X45MM TI| VIPER2 LORDOTIC ROD-50MM| VIPER2 LORDOTIC ROD-50MM