BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM

    MDR report key: 10081873 · Received May 22, 2020

    Report

    Report Number
    3005180920-2020-00288
    Event Type
    Injury
    Date Received
    May 22, 2020
    Date of Event
    April 28, 2020
    Report Date
    May 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030857584
    PMA / PMN Number
    K141988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19-MAY-2020: LOT 1921988: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-AUG-2019. EXPIRATION DATE: 18.08.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. PATIENT MATCH PLANNING REVIEW PERFORMED BY MYSOLUTION DEPARTMENT. OUR ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. ADDITIONAL IMPLANT INVOLVED: PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM (K141988) LOT. 1923102. BATCH REVIEW PERFORMED ON 19-MAY-2020: LOT 1923102: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-OCT-2019. EXPIRATION DATE: 02.10.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A MYSPINE MC SURGERY IN (B)(6) 2020 AND WAS REVISED ONE DAY AFTER DUE TO PAIN, A CAGE HAS BEEN REMOVED. INITIALLY, A DECOMPRESSION WAS ON ONE SIDE, DURING THE REVISION SURGERY IT WAS DONE ALSO ON THE SECOND SIDE. ON (B)(6) OF 2020 THE PATIENT UNDERWENT REVISION SURGERY AGAIN DUE TO PEDICLE SCREWS LOOSENING. THE PATIENT HAS OSTEOPOROTIC BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545841 PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 03.52.323 1921988 07630030857584

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention