BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW REDUCTION PEDICLE SCREW 6X40

    MDR report key: 8649830 · Received May 29, 2019

    Report

    Report Number
    3005180920-2019-00429
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 29, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030846878
    PMA / PMN Number
    K153664
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 MAY 2019: LOT 157314: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2016. EXPIRATION DATE: 2020-12-01. 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. ADDITIONAL IMPLANTS INVOLVED: PEDICLE SCREW 03.50.716 REDUCTION PEDICLE SCREW 6X35 (K153664) LOT 156750: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-NOV-2015. EXPIRATION DATE: 2020-11-07. 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. PEDICLE SCREW 03.50.712 REDUCTION PEDICLE SCREW 5X45 (K153664) LOT 1820241: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2018. EXPIRATION DATE: 2023-06-07. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: PEDICLE FRACTURE DETECTED FEW MONTHS AFTER LUMBAR FUSION SURGERY WITH PEDICLE SCREWS AND RODS. NO HINT OF A TRAUMATIC EVENT THAT LED TO PEDICLE FRACTURE. THE CLINICAL RESULT WAS NON-FUSION AT THE INDEX LEVEL. HOWEVER, THERE IS NO INDICATION IN THE REPORT THAT THE PEDICLE FRACTURE MAY HAVE BEEN CAUSED BY A MALFUNCTIONING DEVICE. WEAKENING OF THE PEDICLE AS A RESULT OF SCREW INTRODUCTION IS INEVITABLE AND CANNOT BE REGARDED AS A FAILURE IN THE DEVICE PERFORMANCES.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A BROKEN L5 VERTEBRA PEDICLE. THE CAUSE OF THE BROKEN PEDICLE IS UNKNOWN, BONE FUSION WAS NOT ACHIEVED. NO REVISION SURGERY HAS BEEN SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442223 PEDICLE SCREW REDUCTION PEDICLE SCREW 6X40 SPINAL PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 157314 07630030846878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention