BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3920007 · Received July 8, 2014

    Report

    Report Number
    2520274-2014-12357
    Event Type
    Injury
    Date Received
    July 8, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ¿COMPARING HOOK PLATES AND KIRSCHNER TENSION BAND WIRING FOR UNSTABLE LATERAL CLAVICLE FRACTURE¿ (2011, NOVEMBER). CHANG, C.-H., YANG, R.-S., AND WU, K. ORTHOPEDICS/ORHTOSUPERSITE, 34:11, E718-E723. THIS REPORT IS FOR AN UNKNOWN HOOK PLATES/UNKNOWN QUANTITY/UNKNOWN LOT. 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, ¿COMPARING HOOK PLATES AND KIRSCHNER TENSION BAND WIRING FOR UNSTABLE LATERAL CLAVICLE FRACTURE¿ (2011, NOVEMBER). CHANG, C.-H., YANG, R.-S., AND WU, K. ORTHOPEDICS/ORHTOSUPERSITE, 34:11, E718-E723. THIS WAS A RETROSPECTIVE OBSERVATIONAL STUDY (LEVEL OF EVIDENCE, II-2). ALL PATIENTS WITH UNSTABLE NEER TYPE II LATERAL CLAVICLE FRACTURES WERE OPERATED ON IN THE INSTITUTE FROM JANUARY 2007 TO JULY 2010. THE INCLUDED PARTICIPANTS RECEIVE EITHER K-WIRE TENSION BAND OR HOOK PLATE OPERATIONS. NINETY-TWO PATIENTS RECEIVED CLAVICULAR HOOK PLATE (SYNTHES, (B)(4)) FIXATION, AND 24 PATIENTS WERE STABILIZED WITH K-WIRE FIXATION. NINETY-TWO PATIENTS WITH UNSTABLE FRACTURES OF THE LATERAL CLAVICLE WERE TREATED WITH CLAVICULAR HOOK PLATE FIXATION. FIFTY-FIVE MEN AND 37 WOMEN HAD A MEAN AGE OF 49.3_15.54 YEARS (RANGE, 22-80 YEARS). COMPLICATIONS IN THE HOOK PLATE GROUP INCLUDED 7 PERIPROSTHETIC FRACTURES, 4 PLATE REMOVALS, AND 1 PLATE MALPOSITION IN A 50 YEAR OLD MALE, IN WHICH THE HOOK WAS NOT INSERTED INTO THE SUBACROMIAL SPACE. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN HOOK PLATES AND THE (B)(6) MALE WHO UNDERWENT REVISION SURGERY FOR PLATE MALPOSITION. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396429 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention