BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW TWO-STEP REDUCER ENHANCED

    MDR report key: 8041553 · Received November 6, 2018

    Report

    Report Number
    3005180920-2018-00861
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 9, 2018
    Report Date
    November 6, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630971226418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION PERFORMED OCTOBER THE 30TH, 2018 BY THE R&D PROJECT MANAGER: ONE OUT OF THE FOUR RETAINING PINS (INTERFACE TO THE IMPLANT - PEDICLE SCREW HEAD) ARE MISSING, DUE TO FAILURE OF THE WELDING. THE CAUSE OF PIN BREAKAGE CAN BE EXCESSIVE STRESS RELATED TO EXCESSIVE REDUCTION FORCE APPLIED AND/OR OTHER FORCES (E.G. LATERAL BENDING), OR EXISTING DAMAGE/DEFORMATION OF THE PIN FROM A PREVIOUS SURGERY. THE INSTRUMENT SET INCLUDES BACKUP INSTRUMENTS. BATCH REVIEW PERFORMED ON NOVEMBER 6, 2018: LOT 1850157: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 JUNE 2018. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, NO SIMILAR EVENT ON THE SAME LOT HAS BEEN REGISTERED. ADDITIONAL COMPONENTS INVOLVED: PEDICLE SCREW 03.50.031 PEDICLE SCREW 7X45, LOT 1820670: 150 ITEMS MANUFACTURED AND RELEASED ON 30 AUGUST 2017 . EXPIRATION DATE: 2023-08-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE,(B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PEDICLE SCREW 03.50.031 PEDICLE SCREW 7X45, LOT. 1820671: 150 ITEMS MANUFACTURED AND RELEASED ON 7 AUGUST 2018. EXPIRATION DATE: 24.07.2023-07-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT (3 ITEMS INVOLVED).

    Description of Event or Problem · 1

    DURING SURGERY AT L3-S1, THE SURGEON TRIED TO INSERT THE 6 PEDICLE SCREWS WITH THE TWO-STEP REDUCER ENHANCED. HE WAS ABLE TO INSERT ONLY 1 SET SCREW AND THEN THE PIN OF THE TIP BROKE DURING THE INSERTION AT L4. THE SURGEON DISCOVERED THE BROKEN PIECE DURING THE SURGERY. THE TWO-STEP REDUCER BROKE WHILE THE SURGEON WAS TIGHTENING EITHER LOT 1820670 OR 1820671. NO DEBRIS HAS FALLEN INTO THE PATIENT, THE SURGERY HAS BEEN COMPLETED WITH A BACK-UP INSTRUMENT. BECAUSE OF THIS ISSUE, THE SURGERY WAS PROLONGED OF 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881012 PEDICLE SCREW TWO-STEP REDUCER ENHANCED SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA 1850157 07630971226418

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other