BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENT ROD TI 5.5X75MM

    MDR report key: 13365947 · Received January 27, 2022

    Report

    Report Number
    3005180920-2022-00051
    Event Type
    Injury
    Date Received
    January 27, 2022
    Date of Event
    December 9, 2021
    Report Date
    January 27, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030835575
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26-JAN-2022: LOT 1820271: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUN-2018. EXPIRATION DATE: 2023-05-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 26-JAN-2022: PEDICLE SCREW 03.50.458 BENT ROD TI 5.5X75MM (K121115) LOT 1920015: (B)(4) ITEMS MANUFACTURED AND RELEASED ON12-AUG-2019. EXPIRATION DATE: 2024-07-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY MEDACTA R&D SPINE PROJECT MANAGER: DURING THE VISUAL INSPECTION IT HAS BEEN ANALYZED: REF. 03.50.458 - BENT ROD TI 5.5X45MM - LOT. 1820271. REF. 03.50.458 - BENT ROD TI 5.5X45MM - LOT. 1920015. THE ROD ARE CONFORMING FOR THE DIMENSIONAL POINT OF VIEW EITHER FOR THE MATERIAL. A SPECIFIC ANALYSIS OF THE MATERIAL HAS BEEN PERFORMED BY THE CONTROL DEPARTMENT AND THE CHECK (SEE CERTIFICATE ATTACHED) CONFIRMED THE MATERIAL (TI6AL4V). THE FRACTURE OF THE ROD SEEMS COMPATIBLE WITH THE APPLICATION OF FLEXTION-EXTENSION LOAD. THE ROOT CAUSE OF THE BREAKAGE IS UNCLEAR.

    Description of Event or Problem · 0

    DURING REVISION SURGERY, TWO MUST RODS WERE REMOVED AND ONE (PEDICLE SCREW 03.50.458, BENT ROD TI 5.5X75MM, LOT 1820271) WAS DISCOVERED TO BE BROKEN. THE PRIMARY SURGERY DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258988 BENT ROD TI 5.5X75MM SPINE ROD KWP MEDACTA INTERNATIONAL SA 03.50.458 1820271 07630030835575

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention