BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW 6X45

    MDR report key: 8764349 · Received July 5, 2019

    Report

    Report Number
    3005180920-2019-00547
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 7, 2019
    Report Date
    July 5, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030834219
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 JUL 2019 LOT 1820660: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2018. EXPIRATION DATE: 23-08-2023. 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. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER OF THE ITEMS RETURNED: THE PEDICLE SCREW HEADS AND THE SETSCREWS ARE DAMAGED IN THE THREADED AREA. THE ROOT CAUSE OF THE DAMAGING IS PROBABLY DUE TO THE CROSS THREADING OF THE SETSCREW INTO THE PEDICLE SCREW HEAD. THE ASSEMBLING OF THE SETSCREW WITHOUT ANY REDUCTION DEVICE, THAT AIM THE SETSCREW CENTERING, INCREASE THE RISK OF CROSSTHREADING. ADDITIONAL INFORMATION: IN CASE OF NEED, THE USAGE OF THE SETSCREWDRIVER ENHANCED, REF. 03.51.10.0218, CAN HELP DURING THE INSERTION OF THE SETSCREW WITH CENTERING OF THE PEDICLE SCREW HEAD WITHOUT THE USAGE OF A REDUCTION DEVICE. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 03 JUL 2019: PEDICLE SCREW 03.50.018 PEDICLE SCREW 6X45 (K121115) LOT. 165546 LOT 165546: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2016. EXPIRATION DATE: 09-11-2021. 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. PEDICLE SCREW 03.50.204 MUST COMBINED SETSCREW H4-T27 - (4X) (K171758) LOT. 1920259 LOT 1920259: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-APR-2019. EXPIRATION DATE: 10-03-2024. 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. IN THIS COMPLAINT TWO DEVICES WITH THE SAME LOT WERE INVOLVED.

    Description of Event or Problem · 1

    PLIF SURGERY WAS PERFORMED AT L4-L5. THE SURGEON WAS NOT ABLE TO INSERT THE SET SCREWS INTO THE PEDICLE SCREW HEAD AT THE LEFT SIDE OF L4, SO THE SURGEON DISENGAGED THE SET SCREW, AND DISCOVERED CROSS-THREADING ON 2 SET SCREWS. EVEN THOUGH THE SURGEON REPLACED THE NEW SET SCREW, CROSS-THREADING REOCCURRED, SO THE SURGEON HAD TO REPLACE THE NEW PEDICLE SCREW. THE SAME EVENT ALSO OCCURRED AT THE RIGHT SIDE OF L4. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558799 PEDICLE SCREW 6X45 SPINE PEDICLE SCREW KWP MEDACTA INTERNATIONAL SA 1820660 07630030834219

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other