BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4681255 · Received April 10, 2015

    Report

    Report Number
    2520274-2015-12600
    Event Type
    Injury
    Date Received
    April 10, 2015
    Report Date
    March 31, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. LENZA, M; ET AL; (2009) SURGICAL INTERVENTIONS FOR TREATING ACUTE FRACTURES OR NONUNION OF THE MIDDLE THIRD OF THE CLAVICLE (REVIEW), THE COCHRANE COLLABORATIONS, 4, 21-22. THIS REPORT IS FOR AN UNKNOWN PLATE (PART/UNKNOWN QUANTITY/UNKNOWN LOT. THE INVESTIGATION COULD NOT BE COMPLETED; 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 SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: LENZ,M; ET AL; (2009) SURGICAL INTERVENTIONS FOR TREATING ACUTE FRACTURES OR NONUNION OF THE MIDDLE THIRD OF THE CLAVICLE (REVIEW), THE COCHRANE COLLABORATIONS, 4, 21-22. THIS REVIEW COVERS TWO CONDITIONS. THESE ARE ACUTE FRACTURES AND NON-UNION RESULTING FROM FAILED FRACTURE HEALING. CLAVICLE OR COLLARBONE FRACTURES ACCOUNT FOR AROUND 4% OF ALL FRACTURES. WHILE TREATMENT OF THESE FRACTURES IS USUALLY NON-OPERATIVE, SOME TYPES OF FRACTURES, AS WELL AS NON-UNION OF THE MIDDLE THIRD OF THE CLAVICLE, ARE OFTEN TREATED SURGICALLY. THIS STUDY REFERS TO 36 PARTICIPANTS IN A HOSPITAL IN TURKEY FROM 01/03/1996 TO 30/07/2000. OPEN REDUCTION AND INTERNAL FIXATION USING THE LIMITED CONTAC DYNAMIC COMPRESSION PLATE (LC-DCP) VERSUS THE DYNAMIC COMPRESSION PLATE (DCP) FOR TREATING NON-UNION OF THE MIDDLE THIRD OF THE CLAVICLE WAS ASSESSED IN 33 PATIENTS WITH MID-CLAVICULAR NON-UNION. THREE SPORTSMEN IN EACH GROUP, ONLY THOSE OF THE DCP GROUP REPORTED MILD BUT NOT RESTRICTING PAIN AFTER HEAVY EXERCISE AT 12 MONTHS. AT THE SAME FOLLOW-UP TIME, THREE OTHER PARTICIPANTS OF THIS GROUP COMPLAINED OF OCCASIONAL PAIN RELATED TO CHANGES IN THE WEATHER. THIS RESOLVED AFTER IMPLANT REMOVAL. THERE WERE TWO TREATMENT FAILURES WHERE UNION WAS NOT ACHIEVED IN THE DCP GROUP. UNION WAS ACHIEVED SUBSEQUENTLY IN BOTH PATIENTS AFTER A FURTHER OPERATION. THE DIFFERENCE BETWEEN THE TWO GROUPS DID NOT REACH STATISTICAL SIGNIFICANCE. SIGNIFICANTLY FEWER PARTICIPANTS IN THE LC-DCP GROUP REQUIRED PLATE REMOVAL (TWO VERSUS EIGHT), PRIMARILY DONE FOR COSMESIS (TWO VERSUS FIVE). ALL PARTICIPANTS OF THE LC-DCP GROUP RETURNED TO THEIR ORIGINAL OCCUPATIONS, WHEREAS TWO FORMER TRUCK DRIVERS IN THE DCP GROUP CHANGED THEIR JOBS BECAUSE OF LIMITATIONS IN SHOULDER MOBILITY. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LC-DCP AND DCP AND REFERS TO UNKNOWN PATIENTS WHO EXPERIENCED SERIOUS INJURY OF PAIN, NONUNION, REVISION AND IMPLANT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239340 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention