BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (6X)

    MDR report key: 8416467 · Received March 13, 2019

    Report

    Report Number
    3005180920-2019-00144
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    February 12, 2019
    Report Date
    March 13, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630040717069
    PMA / PMN Number
    K171758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE VISUAL INSPECTION HAS BEEN PERFORMED ON: PEDICLE SCREW 7X50, REF. (B)(4), LOT. 1820673. MUST COMBINED SET SCREW - (6X), REF. (B)(4), LOT. 1820486 (3 PCS). MUST COMBINED SET SCREW - (4X), REF. (B)(4), LOT. 1820860 (4 PCS). THE LOT. 1820673 HAS THE PEDICLE HEAD WITH A CLEAR DAMAGING OF THE THREAD, PARTICULARLY ON ONE SIDE. ALL THE PCS OF THE LOT. 1820486 HAVE DAMAGING OF THE THREAD. IN PARTICULAR, ONE SCREW, INDICATED IN THE PICTURE WITH AN ARROW IT'S PARTICULARLY DAMAGED. THE LOT NUMBER IS DIFFICULT TO READ DUE TO THE WEARING BUT VISIBLE ON THE MICROSCOPE. IT'S NOT POSSIBLE TO USE ANY KIND OF TEMPORARY SET SCREWDRIVER ON IT. ALL THE PCS OF THE LOT. 1820860 HAVE DAMAGING OF THE THREAD. THE ROOT CAUSE OF THE EVENT IS PROBABLY DUE TO A CROSS-THREADING OF THE PEDICLE SCREW, LOT 1820673, WITH THE SET SCREW, LOT 1820486. THIS EVENT HAS DAMAGED THE TULIP THREAD AND THE SET SCREW. ALL THE DAMAGING OF THE SET SCREW OCCURRED AFTER THIS EVENT IS DUE TO THE DAMAGED INTERFACE OF THE TULIP. BATCH REVIEW PERFORMED ON 12 MARCH 2019: LOT 1820486: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUN-2018. EXPIRATION DATE: 2023-05-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE ALREADY BEEN SOLD WITHOUT ANY OTHER SIMILAR EVENT REPORTED. THE CURRENT CASE INVOLVED 3 PIECES OF THIS LOT. ADDITIONAL COMPONENTS INVOLVED: PEDICLE SCREW (B)(4) MUST COMBINED SET SCREW H4-T27 - (4X), ((B)(4)) LOT 1820860: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUN-2018. EXPIRATION DATE: 2023-05-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE ALREADY BEEN SOLD WITHOUT ANY OTHER SIMILAR EVENT REPORTED. THE CURRENT CASE INVOLVED 4 PIECES OF THIS LOT. PEDICLE SCREW (B)(4) PEDICLE SCREW 7X50 ((B)(4)), LOT 1820673: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2018. EXPIRATION DATE: 2023-04-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE ALREADY BEEN SOLD WITHOUT ANY OTHER SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    AFTER IMPLANTING THE PEDICLE SCREWS, IT WAS DIFFICULT TO FIX THE ROD ON THE LEFT SIDE. WHEN THE CAGE ON L5-S1 WAS INSERTED, THE SURGEON TRIED TO PERFORM SOME COMPRESSION FORCE ON THE SEGMENT, AT THIS TIME, WHEN THEY TRIED TO FIX THE COMBINED SET SCREW, 2 THREADS OF 2 SET SCREWS HAVE BEEN BROKEN. THE SURGERY HAS BEEN COMPLETED SUCCESSFULLY USING A NEW ROD, DEFORMED A LITTLE BIT MORE AND NEW SET SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210332 PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (6X) PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 1820486 07630040717069

    Patients

    Seq Age Sex Outcome Treatment
    1 Other