BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, NAIL

    MDR report key: 6511810 · Received April 21, 2017

    Report

    Report Number
    2520274-2017-11449
    Event Type
    Injury
    Date Received
    April 21, 2017
    Report Date
    March 27, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MIDTERM RESULTS OF 58 FRACTURES OF THE CORONOID PROCESS OF THE ULNA AND THEIR CONCOMITANT INJURIES. THE OPEN ORTHOPAEDICS JOURNAL, VOLUME 7, PP. 86-93. (2013). THIS REPORT IS FOR UNKNOWN EXTERNAL FIXATION DEVICES, UNKNOWN QUANTITY, UNKNOWN LOT. (B)(4): REVISION SURGERY, COMPARTMENT SYNDROME, JOINT MICE, PSEUDARTHROSES OF THE ULNA, JOINT INSTABILITY, WORSENED MOBILITY. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    LITERATURE ARTICLE RECEIVED : THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: KIENE, J., WALDCHEN, J., PAECH, A., JURGENS, CH., SCHULZ, A.P. (2013). MIDTERM RESULTS OF 58 FRACTURES OF THE CORONOID PROCESS OF THE ULNA AND THEIR CONCOMITANT INJURIES. THE OPEN ORTHOPAEDICS JOURNAL, VOLUME 7, PP. 86-93. GERMANY. THE PURPOSE OF THE STUDY WAS TO PROGNOSTICALLY DETERMINE RELEVANT FACTORS FOR THE THERAPY RECOMMENDATION TO TREAT FRACTURES OF THE CORONOID PROCESS. THE STUDY WAS CONDUCTED OVER AN 8 YEAR PERIOD FROM 2001 TO 2009 AND INCLUDED SEVENTY SEVEN (77) PATIENTS (41 FEMALE, 36 MALE) WITH AN AGE RANGE OF 15-79 YEARS (MEAN AGE OF 51.8 YEARS). THE FRACTURES WERE TREATED WITH A COMBINATION OF UNKNOWN SCREWS, UNKNOWN MINI PLATES, LASSO SLINGS, OSSCEOUS REPLACEMENT, AND ISOLATED FRAGMENT RESECTION. A TOTAL OF TWENTY THREE (23) PATIENTS WERE TREATED WITH UNKNOWN SYNTHES EXTERNAL FIXATION DEVICES. THE FOLLOWING COMPLICATIONS WERE REPORTED: - 15 PATIENTS TREATED WITH EXTERNAL FIXATION DEVICES NEEDED REVISION SURGERY; - 7 PATIENTS NOT TREATED WITH EXTERNAL FIXATION DEVICES NEEDED REVISION SURGERY; - 10 PARTIAL OR COMPLETE NERVE LESIONS WERE NOTED POSTOPERATIVELY; - COMPARTMENT SYNDROME; - JOINT MICE; - PSEUDARTHROSES OF THE ULNA; - NON-UNION; - PERSISTENT LUXATIONS REQUIRING COMPLETE ELBOW JOINT PROSTHESIS; - LIGAMENT DAMAGE; - PAIN RANGING FROM SLIGHT TO SEVERE DEPENDING ON THE LOAD; - JOINT INSTABILITY; - WORSENED MOBILITY. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN EXTERNAL FIXATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293639 APPLIANCE, FIXATION, NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention