BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWS: MPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30

    MDR report key: 8878374 · Received August 9, 2019

    Report

    Report Number
    3005180920-2019-00675
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 16, 2019
    Report Date
    August 9, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812392
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 JULY 2019: LOT 1902135: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-APR-2019. EXPIRATION DATE: 2024-03-19. 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. ANOTHER IMPLANT INVOLVED (IT IS UNKNOWN IF THE BROKEN SCREW IS THIS ONE OR THE PREVIOUS LISTED ONE, THE BROKEN SCREW IS ONLY ONE). SCREWS: MPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30 LOT. 178057 (K103721). BATCH REVIEW PERFORMED ON 26 JULY 2019: LOT 178057: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-DEC-2017. EXPIRATION DATE: 2022-11-22. 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.

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS SCREWING ONE OF THE TWO IMPLANTED SCREWS, THE HEAD OF THE SCREW BROKE AND REMAINED ON THE SCREWDRIVER. THE THREADED BODY REMAINED IMPLANTED (IN THE CORRECT POSITION) IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672806 SCREWS: MPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30 HIP BONE SCREW LPH MEDACTA INTERNATIONAL SA 1902135 07630030812392

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other