BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 3790911 · Received May 5, 2014

    Report

    Report Number
    2520274-2014-11202
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 9, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NIJ, S., GRAELER, H., BELLEMANS, J. (2011). FIXING SIMPLE OLECRANON FRACTURES WITH THE OLECRANON OSTEOTOMY NAIL (OLEON). OPER ORTHOP TRAUMATOL 23:438-445. THIS REPORT IS FOR AN UNKNOWN OLECRANON OSTEOTOMY NAIL. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: FIXING SIMPLE OLECRANON FRACTURES WITH THE OLECRANON OSTEOTOMY NAIL (OLEON); NIJ, S., GRAELER, H., BELLEMANS, J. (2011). FIXING SIMPLE OLECRANON FRACTURES WITH THE OLECRANON OSTEOTOMY NAIL (OLEON). OPER ORTHOP TRAUMATOL 23:438-445. THIS ARTICLE DESCRIBED THE SURGICAL TECHNIQUE OF AND THE CLINICAL EXPERIENCE WITH THE OLECRANON OSTEOTOMY NAIL (SYNTHES). BETWEEN (B)(6) 2009 AND (B)(6) 2011, 21 PATIENTS (8 MALE AND 13 FEMALE AGES RANGING FROM 20-85 YEARS WITH AN AVERAGE OF 42 YEARS) WERE TREATED WITH THE OLECRANON OSTEOTOMY NAIL. A TOTAL OF 6 COMPLICATIONS WERE OBSERVED. ONE PATIENT EXPERIENCED A PERI-IMPLANT FRACTURE THAT REQUIRED REVISION. THREE PATIENTS EXPERIENCE DECREASED MOBILITY AS A RESULT OF ECTOPIC OSSIFICATION AND ONE PATIENT DEVELOPED AN ARTHROFIBROTIC ELBOW. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN OLECRANON OSTEOTOMY NAIL. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267371 NAIL, FIXATION, BONE JDS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention