BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3982292 · Received August 5, 2014

    Report

    Report Number
    2520274-2014-12737
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:DEVICE USED FOR TREATMENT NOT DIAGNOSIS. THE WRONG ATTACHMENT WAS SENT PREVIOUSLY; A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. YU, G., XIA, J., ZHOU, J., & YANG, Y.(2012) LOW-ENERGY FRACTURE OF POSTEROLATERAL TIBIAL PLATEAU: TREATMENT BY A POSTEROLATERAL PRONE APPROACH. J TRAUMA 72, 1416-1423. THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION PLATE. (B)(6). 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: LOW-ENERGY FRACTURE OF POSTEROLATERAL TIBIAL PLATEAU: TREATMENT BY A POSTEROLATERAL PRONE APPROACH. YU, G., XIA, J., ZHOU, J., & YANG, Y.(2012) LOW-ENERGY FRACTURE OF POSTEROLATERAL TIBIAL PLATEAU: TREATMENT BY A POSTEROLATERAL PRONE APPROACH. J TRAUMA 72, 1416-1423. THIS WAS A RETROSPECTIVE STUDY OF 15 PATIENTS (4 WOMEN, 11 MEN, AVERAGE AGE AT TIME OF INJURY WAS 53.3 YEARS WITH RANGE 36-78 YEARS) BETWEEN MAY 2007 AND APRIL 2010. THE PATIENT'S HAD FRACTURES OF THE TIBIA THAT WERE CLASSIFIED AS LOW-ENERGY POSTEROLATERAL FRACTURES. DURING THAT PERIOD, THE TIBIAL PLATEAU FRACTURES WERE TREATED WITH A PRECONTOURED BUTTRESS PLATE (3.5 MM T PLATE, STRAIGHT OR OBLIQUE, SYNTHES OR THIRD PARTY) AND SCREWS (UNSPECIFIED). THERE WERE NO MECHANICAL COMPLICATIONS. TWO PATIENTS EXPERIENCED 2 SLIGHT FLEXION CONTRACTURES (BOTH LACKED 5 DEGREES OF EXTENSION). THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456475 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention