BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXP TI UNI SCW 5MMX35MM

    MDR report key: 19013386 · Received April 1, 2024

    Report

    Report Number
    1526439-2024-01165
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    UDI-DI
    10705034081212
    PMA / PMN Number
    K160904
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D2B: ADDITIONAL PRODUCT CODES: KWP,KWQ,NKB,MNI,OSH D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E1: (B)(6). E3: REPORTER IS A J&J SALES REPRESENTATIVE. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN SURGERY FOR AIS PERFORMED ON AN UNKNOWN DATE, THE SET SCREW IN QUESTION CROSS-THREADED DURING FINAL FASTENING. THE SET SCREWS WERE CHANGED SEVERAL TIMES, BUT IT DID NOT SOLVE. THE SURGEON TIGHTENED IT MANUALLY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) EXP TI UNI SCW 5MMX35MM THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867056 EXP TI UNI SCW 5MMX35MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD MNH MEDOS INTERNATIONAL SàRL CH 10705034081212

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SINGLE-INNER SETSCREW| SINGLE-INNER SETSCREW| SINGLE-INNER SETSCREW