BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTA C VARIABLE SELF-DRILLING SCREW DIAM. 4X18MM (2X)

    MDR report key: 14797028 · Received June 24, 2022

    Report

    Report Number
    3005180920-2022-00482
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWQ
    UDI-DI
    07630030840043
    PMA / PMN Number
    K140361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 JUNE 2022. LOT 2121007:(B)(4). EXPIRATION DATE: 2026-04-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). OTHER DEVICE POTENTIALLY INVOLVED (IT IS UNKNOWN WHICH LOT IS THE BROKEN ONE): MECTA C 03.70.020 VARIABLE SELF-DRILLING SCREW DIAM. 4X18MM (2X) (K140361) LOT. 1620618: (B)(4). EXPIRATION DATE: 2025-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT ABOUT 4 MONTHS AFTER CERVICAL STABILIZATION SURGERY, ON POSTOPERATIVE EXAMINATION, AN X-RAY IMAGE SHOWS THAT ONE OF THE SCREWS HAS PARTIALLY BACKED OUT. FROM THE ONE IMAGE PROVIDED, THE SCREW ITSELF IS ALSO BROKEN. THE BACK OUT IS SMALL AND NOT CLINICALLY DANGEROUS AT THE MOMENT; IN FACT, THE SURGEON DECIDED NOT TO REVISE. THE CAUSES OF THE BACK OUT ARE CURRENTLY UNKNOWN; IN CASE OF REINTERVENTION, IT WILL BE POSSIBLE TO ANALYZE THE EXPLANTS AND PERHAPS FORMULATE A HYPOTHESIS.

    Description of Event or Problem · 0

    ABOUT 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND X-RAYS REVEALED THAT A SCREW HAD BACKED OUT AT C6 AND BROKE. IT IS UNKNOWN HOW THIS OCCURRED AND WHICH OF REPORTED LOTS WAS INVOLVED. THE SURGEON PLANS TO MONITOR THE PATIENT AND NOT REVISE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957892 MECTA C VARIABLE SELF-DRILLING SCREW DIAM. 4X18MM (2X) SPINE CERVICAL SCREW KWQ MEDACTA INTERNATIONAL SA 03.70.020 2121007 07630030840043

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other