BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW BENT ROD TI 5.5X45MM

    MDR report key: 8141712 · Received December 7, 2018

    Report

    Report Number
    3005180920-2018-00974
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    November 6, 2018
    Report Date
    February 7, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030835513
    PMA / PMN Number
    K121115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE BREAKAGE OCCURRED BELOW THE HEAD OF THE SCREW, WHICH IS THE MOST STRESSED POINT AS EXPECTED BY THE RISK ANALYSIS. THERE IS NO SIGN OF MATERIAL OR GEOMETRY DEFECT THAT COULD HAVE CAUSED THE FAILURE. THE BREAKAGE APPEARS AS A TYPICAL FAILURE OF THE IMPLANT UNDER FATIGUE LOADING. THIS KIND OF BREAKAGE IS A COMMON EVENT FOR PEDICLE SCREWS IN CASE OF DELAYED FUSION, OR SCREW LOOSENING, OR SPINAL CONSTRUCT INSTABILITY, WHICH MIGHT BE CAUSED BY DIFFERENT NON-DEVICE-RELATED CAUSES.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 DECEMBER 2018: LOT 1720407: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCTOBER-2017. EXPIRATION DATE: 2022-10-01. 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. ADDITIONAL COMPONENT INVOLVED: PEDICLE SCREW 03.50.017 PEDICLE SCREW 6X40 (K121115) LOT 1720749: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2017. EXPIRATION DATE: 2022-10-04. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: TEN MONTHS AFTER PRIMARY LUMBO-SACRAL STABILIZATION BY PEDICLE SCREWS ONE OF THE SACRAL SCREWS WAS FOUND BROKEN ALONG WITH ONE OF THE 45MM PRE-BENT RODS. PROBABLY FUSION DID NOT TAKE PLACE AND IN THESE CONDITIONS THE FATIGUE LIFE OF THE STABILIZING DEVICES IS LIMITED. FROM THE CLINICAL POINT OF VIEW, A POSSIBLE CAUSE FOR THE FAILURE IS LACK OF FUSION. TECHNICAL INVESTIGATION SHOULD BE CARRIED OUT ON THE EXPLANTS TO EXCLUDE POSSIBLE DEFECTS.

    Description of Event or Problem · 1

    FIRST SURGERY: (B)(6) 2018; STABILIZATION L5-S1 (6X40 SCREWS AND 45MM TI PREBENT RODS). AFTER 3 MONTHS FROM FIRST SURGERY, A TAC EXAM REVEALED THE BREAKAGE OF THE RIGHT ROD AND THE LEFT SCREW IN S1. THE PATIENT WAS RE-OPERATED ON (B)(6): REMOVAL OF ALL SCREWS AND ROD (THE DISTAL PART OF THE BROKEN SCREW REMAINS IN THE SACRUM) AND FIXATION L4-S1 WITH COMPETITOR STABILIZATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981045 PEDICLE SCREW BENT ROD TI 5.5X45MM PEDICLE SCREW ROD KWP MEDACTA INTERNATIONAL SA 1720407 07630030835513

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention