BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X55

    MDR report key: 9165880 · Received October 8, 2019

    Report

    Report Number
    3005180920-2019-00862
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    September 19, 2019
    Report Date
    October 8, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OUR
    UDI-DI
    07630030881114
    PMA / PMN Number
    K171595
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 OCTOBER 2019: LOT 1720491: 80 ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2018. EXPIRATION DATE: 2023-03-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITION IMPLANTS INVOLVED IN THE EVENT: SACRO-ILIAC SCREW SYSTEM 03.65.704 SI-JOINT SCREW 10X40 (K171595) LOT. 1720488. BATCH REVIEW PERFORMED ON 08 OCTOBER 2019: LOT 1720488: 47 ITEMS MANUFACTURED AND RELEASED ON 09-APR-2018. EXPIRATION DATE: 2023-03-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 35 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. TWO DEVICES OF THIS LOT INVOLVED IN THIS COMPLAINT. ADDITION IMPLANTS INVOLVED IN THE EVENT: SACRO-ILIAC SCREW SYSTEM 03.65.903 STANDARD WASHER Ø17MM, TI (K171595) LOT. 1720499. BATCH REVIEW PERFORMED ON 08 OCTOBER 2019: LOT 1720499: 58 ITEMS MANUFACTURED AND RELEASED ON 09-APR-2018. EXPIRATION DATE: 2023-03-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 41 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. TWO DEVICES OF THIS LOT INVOLVED IN THIS COMPLAINT. ADDITION IMPLANTS INVOLVED IN THE EVENT: SACRO-ILIAC SCREW SYSTEM 03.65.901 STANDARD WASHER Ø13MM, TI (K171595) LOT. 1720497. BATCH REVIEW PERFORMED ON 08 OCTOBER 2019: LOT 1720497: 72 ITEMS MANUFACTURED AND RELEASED ON 09-APR-2018. EXPIRATION DATE: 2023-03-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 59 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 9 MONTHS AFTER PRIMARY THE SURGEON DECIDED TO REVISE THE IMPLANTS FOR LOOSENING IN THE SACRUM. EXPLANTATION WAS DIFFICULT AND CAUSED A LOT OF MUSCULAR DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963595 SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X55 SACRO-ILIAC SCREW OUR MEDACTA INTERNATIONAL SA 1720491 07630030881114

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention