BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM

    MDR report key: 16021055 · Received December 21, 2022

    Report

    Report Number
    3005180920-2022-00978
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    December 8, 2022
    Report Date
    February 9, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030857577
    PMA / PMN Number
    K141988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 DECEMBER 2022. LOT 2221113: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAR-2022. EXPIRATION DATE: 2027-FEB-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW (2 DEVICES REPORTED IN THIS COMPLAINT).

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D MANAGER: THE PEDICLE SCREW (REF. 03.52.322, LOT 2221113) HAS BEEN ANALYZED AND IS CONFORMING TO SPECIFICATION. THE MYSPINE PLANNING HAS BEEN REVIEWED AND NO ANOMALIES WERE FOUND. NO ROOT CAUSE CAN BE DEFINED. MYSOLUTION DEPARTMENT EVALUATION: THE ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY.

    Description of Event or Problem · 0

    L4/5 FIXATION SURGERY. THE PATIENT'S PEDICLES ON L4 BROKE DURING SCREW INSERTION. LARGER SIZE SCREWS WAS USED TO COMPLETE THE SURGERY. THE SURGEON DRILL THE HOLE, THEN 5 MM TAPPING AND 6 MM TAPPING. K-WIRE WAS USED. BONE QUALITY NORMAL. NO SKIVING PROBLEM OCCURRED DURING INSERTION.

    Description of Event or Problem · 0

    L3-L4 FIXATION SURGERY. THE PATIENT'S PEDICLES ON L3 BROKE DURING SCREW INSERTION. LARGER SIZE SCREWS WAS USED TO COMPLETE THE SURGERY. THE SURGEON DRILL THE HOLE, THEN 5 MM TAPPING AND 6 MM TAPPING. K-WIRE WAS USED. BONE QUALITY NORMAL. NO SKIVING PROBLEM OCCURRED DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024354 PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM SPINE POLY-AXIAL PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 03.52.322 2221113 07630030857577

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other