BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAUMACEM V+CEMENT 10ML KIT STERILE

    MDR report key: 5454396 · Received February 23, 2016

    Report

    Report Number
    2520274-2016-11229
    Event Type
    Injury
    Date Received
    February 23, 2016
    Date of Event
    January 8, 2016
    Report Date
    February 9, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT AGE/DATE OF BIRTH IS UNKNOWN; YEAR OF BIRTH REPORTED AS 1941. PATIENT WEIGHT IS UNKNOWN. DATE OF EVENT REPORTED AS (B)(6) 2016; IT IS UNKNOWN IF THAT IS WHEN THE LOSS OF REDUCTION OCCURRED OR WHEN IT WAS NOTICED. THIS REPORT IS FOR AN UNKNOWN CEMENT KIT/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). INITIALLY REPORTED AS (B)(6) 2016; SHOULD BE (B)(6) 2016. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    INITIALLY REPORTED DEVICE PRODUCT CODE AND COMMON NAME (NDN, POLYMETHYLMETHACRYLATE BONE CEMENT) WAS CORRECT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: CLINICAL STUDY CASE: IT WAS REPORTED THAT LOSS OF REDUCTION OCCURRED, WHICH WAS CORRECTED BY REVISION TO REVERSE TOTAL SHOULDER ARTHROPLASTY. THE REVISION TOOK PLACE ON (B)(6) 2016. THE PHILOS IMPLANTS WERE IMPLANTED ON (B)(6) 2015. THIS REPORT IS FOR AN UNKNOWN CEMENT KIT. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111134 TRAUMACEM V+CEMENT 10ML KIT STERILE POLYMETHYLMETHACRYLATE BONE CEMENT NDN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention