BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X45MM

    MDR report key: 7897536 · Received September 21, 2018

    Report

    Report Number
    3005180920-2018-00711
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    August 22, 2018
    Report Date
    October 31, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030857591
    PMA / PMN Number
    K141988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED THE 30TH OF OCTOBER 2018 BY R&D PRODUCT MANAGER. PICTURES RECEIVED WITH THE COMPLAINT NOTIFICATION WERE ALSO CONSIDERED. FRACTURE OF TWO PEDICLE SCREWS. 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 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 A NUMBER OF NON-DEVICE-RELATED CAUSES.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2018; LOT 1621163: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 FEBRUARY 2017 EXPIRATION DATE: 2022-01-15; 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. OTHER DEVICE INVOLVED: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X50MM REFERENCE 03.52.325; (K141988); LOT 1621164:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 FEBRUARY 2017. EXPIRATION DATE: 2022-01-01. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS (B)(4) ON 21 SEPTEMBER 2018; FEW MONTHS AFTER ONE-LEVEL LUMBAR FUSION WITH PEDICLE SCREWS, THE TWO SCREWS ON L5 SHEARED OFF. NO INFORMATION WERE GIVEN AS TO PATIENT WEIGHT, ACTIVITY, NO TRAUMATIC EVENT WAS REPORTED. THE CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED BY CLINICAL ANALYSIS.

    Description of Event or Problem · 1

    THE SURGEON DETECTED THAT 2 SCREWS BROKE INSIDE THE PATIENT AND HE PLANS TO REVISE THE COMPONENTS ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740605 PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X45MM PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 1621163 07630030857591

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention