BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® LAG SCREW 12.7MM THREAD/75MM

    MDR report key: 4063191 · Received September 5, 2014

    Report

    Report Number
    3009450863-2014-10034
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Report Date
    August 7, 2014
    Manufacturer
    SYNTHES BALSTHAL
    Product Code
    KTT
    PMA / PMN Number
    PK791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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

    IMPLANT DATE: (B)(6) 2014. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. 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 XXX AS FOLLOWS: IT WAS REPORTED THAT IN (B)(6) 2014 AFTER A TRAUMATIC FRACTURE OF THE RIGHT FEMUR THE PATIENT HAD A SURGERY WITH A DYNAMIC CONDYLAR SCREW SYSTEM (DCS). (B)(6) 2014 WITHOUT ANY REPORTED TRAUMA OR OTHER PRECIPITATING FACTOR, THE PATIENT FELT A SEVERE PAIN IN HER LEG. THE PATIENT WENT BACK TO THE HOSPITAL AND A RADIOGRAPH WAS DONE. IT SHOWED A RE-FRACTURE OF THE BONE AND THAT THE DCS WAS BROKEN. ON (B)(6) 2014, THE PATIENT WAS RE-OPERATED AND THE BROKEN DCS WAS REMOVED AND CHANGED WITH INTRA MEDULLARY NAIL. THE PATIENT IS REPORTEDLY STILL HOSPITALIZED WITH PSYCHOLOGICAL COMPLICATIONS, HEALTH PROBLEMS, AND SIDE EFFECTS. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6). THE PATIENT WENT BACK TO THE HOSPITAL AND A RADIOGRAPH WAS DONE. IT SHOWED A RE-FRACTURE OF THE BONE AND THAT THE DCS PLATE AND SCREW WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545249 DHS®/DCS® LAG SCREW 12.7MM THREAD/75MM APPLIANCE, FIXATION, NAIL KTT SYNTHES BALSTHAL 3448538

    Patients

    Seq Age Sex Outcome Treatment
    1