BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER TI SAI POLY 9X90MM

    MDR report key: 12354202 · Received August 23, 2021

    Report

    Report Number
    1526439-2021-01747
    Event Type
    Injury
    Date Received
    August 23, 2021
    Report Date
    July 27, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034265865
    PMA / PMN Number
    K160904
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL PRODUCT CODE: KWP; KWQ; MNH; MNI. 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. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A SURGERY FOR POSTERIOR SPINAL FUSION IN (B)(6) OF 2020. AT A FOLLOW UP APPOINTMENT IN (B)(6) OF 2020, XRAY IMAGES SHOWED THAT THE SET SCREW HAD LOOSENED FROM THE SAI SCREWS BILATERALLY AND THE ROD HAD LOOSENED DUE TO HEAD SPLAY. THE S1 AND L5 SCREWS HAD FRACTURED AT THE NECK OF THE SCREW JUST BELOW THE TULIP. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. THE PATIENT DID NOT ACHIEVE A FUSION BELOW L5 DUE TO THIS HARDWARE FAILURE. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) VIPER TI SAI POLY 9X90 MM. THIS REPORT IS 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250011 VIPER TI SAI POLY 9X90MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB MEDOS INTERNATIONAL SàRL CH 179704990 10705034265865

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5.5 TI CORT FIX 7X45 MM| 5.5 TI CORT FIX 7X45 MM| 5.5 TI CORT FIX 7X45 MM| VIPER TI SAI POLY 9X100 MM| 5.5 TI CORT FIX 7X45 MM| 5.5 TI CORT FIX 7X45 MM| 5.5 TI CORT FIX 7X45 MM| VIPER TI SAI POLY 9X100 MM