BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.0MM TI CABLE WITH CRIMP DOUBLE LEAD 470MM-STERILE

    MDR report key: 5311145 · Received December 18, 2015

    Report

    Report Number
    1719045-2015-10833
    Event Type
    Malfunction
    Date Received
    December 18, 2015
    Date of Event
    October 26, 2015
    Report Date
    October 26, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDQ
    PMA / PMN Number
    PK002110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PART 491.992.01S, LOT P210072: RELEASE TO WAREHOUSE DATE: MAY 14, 2015. EXPIRATION DATE: MARCH 31, 2024. MANUFACTURING SITE IS SYNTHES (B)(4) AND SUPPLIED BY (B)(4). 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 THIS 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). DEVICE BROKE DURING THE PROCEDURE; IT WAS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    IT IS REPORTED DURING AN UNKNOWN SPINAL PROCEDURE AT UNKNOWN LEVELS, SURGEON WAS ATTEMPTING TO TIGHTEN THE SPINE CABLE WHEN THE CABLE BROKE. BROKEN CABLE AND ALL FRAGMENTS WERE RETRIEVED FROM PATIENT. ANOTHER CABLE WAS IMPLANTED AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836879 1.0MM TI CABLE WITH CRIMP DOUBLE LEAD 470MM-STERILE CERCLAGE FIXATION JDQ SYNTHES MONUMENT P210072

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR