BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE

    MDR report key: 6225604 · Received January 5, 2017

    Report

    Report Number
    9612488-2017-10010
    Event Type
    Injury
    Date Received
    January 5, 2017
    Report Date
    December 13, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: LOT NUMBER, EXPIRATION DATE, (B)(4), DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART # 08.501.001.01S, LOT # 9933414: MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4) MANUFACTURING DATE: 13-JULY-2016, EXPIRY DATE: 01-JULY-2021. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: NOVEMBER 22, 2012. EXPIRY DATE: NOVEMBER 01, 2017. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT WAS IMPLANTED WITH THE ZIPFIX SYSTEM ON (B)(6) 2016. POST-OPERATIVELY THE PATIENT PRESENTED WITH MEDIASTINITIS. IT WAS CONFIRMED THIS WAS NOT AN INFECTION; HOWEVER, THE PATIENT DID REQUIRE A REVISION TO REMOVE THREE ZIPFIX DEVICES ON (B)(6) 2016 DUE TO THE REACTION. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7609 STERNAL ZIPFIX WITH NEEDLE STERILE CERCLAGE FIXATION JDQ SYNTHES BETTLACH 9933414

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention