BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 6593749 · Received May 26, 2017

    Report

    Report Number
    2520274-2017-11713
    Event Type
    Injury
    Date Received
    May 26, 2017
    Report Date
    May 1, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. GERELI, A., NALBANTOGLU, U., DIKMEN, G, GOKSEL, D., SEYHAN, M. AND TURKMEN, M. (2015) FRACTURE-DISLOCATIONS OF THE PROXIMAL ULNA. ACTA ORTHOP TRAUMATOL TURC, VOLUME 49(3): 233-240. THIS REPORT IS FOR UNKNOWN ¿ 3.5-MM TITANIUM PRECONTOURED LOCKING-COMPRESSION OLECRANON PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. PART # IS UNKNOWN, 510K IS UNKNOWN. (B)(4). 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE GERELI, A., NALBANTOGLU, U., DIKMEN, G, GOKSEL, D., SEYHAN, M. AND TURKMEN, M. (2015) FRACTURE-DISLOCATIONS OF THE PROXIMAL ULNA. ACTA ORTHOP TRAUMATOL TURC, VOLUME 49(3): 233-240. THE PURPOSE OF THIS ARTICLE IS TO DEFINE SPECIFIC PATTERNS OF INJURY AND INVESTIGATE THE RELATIONSHIP BETWEEN INJURY PATTERN AND FUNCTIONAL OUTCOMES AND COMPLICATIONS IN PROXIMAL-ULNA FRACTURE DISLOCATIONS THIS RETROSPECTIVE ANALYSIS OCCURRED BETWEEN JANUARY 2004 AND JANUARY 2012. THE STUDY INCLUDED FIFTEEN (15) PATIENTS THAT INCLUDED TEN (10) MEN AND FIVE (5) WOMEN WITH A MEAN AGE OF 49.1 (RANGE: 33-75) YEARS. THE MEAN FOLLOW-UP IS 49 MONTHS. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN ¿ 3.5-MM TITANIUM PRECONTOURED LOCKING-COMPRESSION OLECRANON PLATE AND REFERS TO TWO (2) UNKNOWN PATIENT HAD GRADE-I AND ONE (1) UNKNOWN PATIENT HAD GRADE-II OSTEOARTHRITIS IN THE ANTERIOR FRACTURE-DISLOCATION GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376374 PLATE,FIXATION,BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention