BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR HEAD Ø22X41

    MDR report key: 7876589 · Received September 14, 2018

    Report

    Report Number
    3005180920-2018-00686
    Event Type
    Injury
    Date Received
    September 14, 2018
    Date of Event
    August 16, 2018
    Report Date
    September 14, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    UDI-DI
    07630030843310
    PMA / PMN Number
    K091967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 SEPTEMBER 2018. LOT 112862: (B)(4). EXPIRATION DATE: 2016-03-30. 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. COCR BALL HEAD 12/14 Ø 22 SIZE S -2,5 REFERENCE 01.25.124 (K080885). LOT 134979: (B)(4). EXPIRATION DATE: 2018-10-31. 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

    WE WERE INFORMED ON (B)(6) 2018 THAT THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON PLANS TO REVISE THE PATIENT ON (B)(6) 2018. MORE INFORMATION TO FOLLOW THE CASE. UPDATE RECEIVED ON 13 SEPTEMBER 2018: REVISION NOT PERFORMED ON (B)(6) DATE UNKNOWN. TO DATE NO ADDITIONAL INFORMATION ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717523 BIPOLAR HEAD Ø22X41 BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 112862 07630030843310

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention