BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA-LCP DRSL DRP/INTMD CLMN/+90°/2H HD/4H SHAFT

    MDR report key: 4181553 · Received October 17, 2014

    Report

    Report Number
    1000562954-2014-10195
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 23, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    PK102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT: ON THE SURFACE OF THE PLATES SEVERAL TRACES OF THE BENDING TOOL ARE VISIBLE. PLEASE NOTE THAT TITANIUM PLATES MAY NOT BE RE-BENT BACK; SINCE SEVERAL TIMES BACK AND FORTH BENDING WOULD WEAKEN THE MATERIAL (SEE NOTICE IN THE SURGICAL TECHNIQUE GUIDE 016.001.225). THE SUBMITTED VA-LCP PLATES WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS IN DECEMBER 2010 AND IN AUGUST 2013. NO PRODUCT FAULTS COULD BE FOUND. 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE GENERATED DURING PRODUCTION. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING PREPARATION FOR SURGERY THE PLATE BROKE DURING BENDING. THE SURGERY WAS FINALIZED WITH A THIRD PLATE THAT WAS READILY AVAILABLE. THIS IS REPORT NUMBER 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661553 2.4MM TI VA-LCP DRSL DRP/INTMD CLMN/+90°/2H HD/4H SHAFT PLATE,FIXATION,BONE HRS SYNTHES MEZZOVICO 8579602

    Patients

    Seq Age Sex Outcome Treatment
    1