BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER TI SAI POLY 8X70MM

    MDR report key: 10176443 · Received June 19, 2020

    Report

    Report Number
    1526439-2020-01211
    Event Type
    Injury
    Date Received
    June 19, 2020
    Report Date
    June 1, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWP
    UDI-DI
    10705034265704
    PMA / PMN Number
    K111571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H10 ADDITIONAL NARRATIVE: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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

    INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 THAT ON (B)(6) 2015, AN INITIAL SPINAL FUSION WAS PERFORMED FOR KYPHOSIS. THE PROCEDURE WAS FOR BUILDING CONSTRUCT IN T9-S2. ON (B)(6) 2015, A SECOND PROCEDURE WAS PERFORMED FOR OSTEOTOMY IN L1 AND RE-DEPLOYING THE DEVICES STRYKER¿S CONNECTOR AND ROD WHICH WERE IMPLANTED IN THE INITIAL PROCEDURE. THE IMPLANTED ROD WAS CONNECTED TO THE STRYKER¿S CONNECTOR. ON (B)(6) 2018, THE REVISION PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON. THE SURGEON EXPLANTED TWO (2) UNKNOWN EXPEDIUM SCREWS IN S1 AND REPLACED THEM WITH UNKNOWN SCREWS. ALSO, ONE (1) SCREW WAS REPLACED IN S2 LEFT, S2 RIGHT. ONE (1) ROD WAS EXPLANTED AND REPLACED WITH TWO (2) RODS CONNECTED TO THE STRYKER¿S CONNECTOR. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); VIPER TI SAI POLY 8X70MM (PART# 179704870, LOT# UNKNOWN, QUANTITY 1); ROD, 480 MM (PART# 179762480, LOT# UNKNOWN, QUANTITY 1); UNKNOWN LOCKING/SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT IS RELATED TO (B)(4) WHICH INVOLVES FOUR TOTAL PROCEDURES ((B)(6) 2015, (B)(6) 2015, (B)(6) 2018, (B)(6) 2020). THIS REPORT IS FOR ONE (1) VIPER TI SAI POLY 8X70MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640038 VIPER TI SAI POLY 8X70MM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDOS INTERNATIONAL SàRL CH 179704870 10705034265704

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROD, 480 MM| UNKNOWN LOCKING/SET SCREWS| UNKNOWN SCREWS| UNKNOWN SCREWS| VIPER TI SAI POLY 8X70MM