BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4609409 · Received March 17, 2015

    Report

    Report Number
    2520274-2015-11859
    Event Type
    Injury
    Date Received
    March 17, 2015
    Report Date
    February 25, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LIN, H.-Y. ET AL (2014) CLAVICULAR HOOK PLATE MAY INDUCE SUBACROMIAL SHOULDER IMPINGEMENT AND ROTATOR CUFF LESION ¿ DYNAMIC SONOGRAPHIC EVALUATION. JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH, 9:6. THIS REPORT IS FOR AN UNKNOWN CLAVICULAR HOOK PLATE. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LIN, H.-Y. ET AL (2014) CLAVICULAR HOOK PLATE MAY INDUCE SUBACROMIAL SHOULDER IMPINGEMENT AND ROTATOR CUFF LESION ¿ DYNAMIC SONOGRAPHIC EVALUATION. JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH, 9:6. FROM DECEMBER 2007 TO JANUARY 2010, 40 PATIENTS (30 MALE, 10 FEMALE; MEAN AGE 37.68 +/- 12.09) WERE PROSPECTIVELY FOLLOWED WITH UNSTABLE DISTAL CLAVICLE FRACTURES AND AC JOINT DISLOCATIONS. THE PATIENTS WERE TREATED WITH MODIFIED STAINLESS STEEL, 3.5 MM DYNAMIC COMPRESSION PLATE (DCP) CLAVICULAR HOOK PLATE (SYNTHES, (B)(4)). A 40 YEAR OLD MAN HAD SHOULDER IMPINGEMENT SYNDROME BEFORE IMPLANT REMOVAL. THIS REPORT IS FOR AN UNKNOWN CLAVICULAR HOOK PLATE. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180259 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention