BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5027336 · Received August 25, 2015

    Report

    Report Number
    2520274-2015-15183
    Event Type
    Injury
    Date Received
    August 25, 2015
    Report Date
    August 4, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS SOHN, H.-S., KIM, W.J., SHON, M.S.,: COMPARISON BETWEEN OPEN PLATING VERSUS MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS FOR ACUTE DISPLACED CLAVICULAR SHAFT FRACTURES. INJURY. INT. XXX(2015) XXX-XXX. ANATOMICAL CLAVICULAR PLATE (OPEN PLATING)/UNKNOWN LOT. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) . 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: SOHN, H.-S., KIM, W.J., SHON, M.S.,: COMPARISON BETWEEN OPEN PLATING VERSUS MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS FOR ACUTE DISPLACED CLAVICULAR SHAFT FRACTURES. INJURY. INT. XXX(2015) XXX-XXX. A RETROSPECTIVE REVIEW ON A CONSECUTIVE SERIES OF PATIENTS WITH CLAVICULAR SHAFT FRACTURE WHO UNDERWENT OPEN PLATING OR MIPO. FOURTEEN PATIENTS WERE TREATED WITH OPEN PLATING WITH INTERFRAGMENTARY SCREW FIXATION, AND 19 WERE TREATED WITH THE MIPO TECHNIQUE WITHOUT EXPOSING A FRACTURE SITE ITSELF. TOTAL CONSECUTIVE 33 PATIENTS WERE INCLUDED IN THIS STUDY. FOURTEEN PATIENTS WERE TREATED USING THE OPEN TECHNIQUE AND 19 WERE TREATED WITH MIPO TECHNIQUE. THERE WERE 30 MALE AND 3 FEMALE PATIENTS. THE MEAN AGE AT THE TIME OF INJURY WAS 45.7 YEARS (RANGE, 18-70 YEARS). COMPLICATIONS: 1-PATIENT NON-UNION-(MIPO). 4-PATIENTS WITH SKIN NUMBNESS-(OPEN PLATING). (B)(6) YRS. MALE-PATIENT IMPLANT FAILURE DEVELOPED PLATE BREAKAGE-(MIPO). (B)(6) YRS. MALE-PATIENT IMPLANT FAILURE WITH SCREW LOOSENING-(OPEN PLATING). 5-PATIENTS SKIN IRRITATION OR DISCOMFORT DUE TO PLATE PROMINENCE-(MIPO),-(OPEN PLATING). THIS REPORT IS FOR AN UNKNOWN ANATOMICAL CLAVICULAR PLATE (OPEN PLATING). A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 5 COMPLAINT COM-(B)(4). THIS REPORT IS FOR THE SERIOUS INJURY OF 7 PATIENTS THAT EXPERIENCED: 3-PATIENTS SKIN IRRITATION OR DISCOMFORT DUE TO PLATE PROMINENCE (OP), 4-PATIENTS WITH SKIN NUMBNESS (OP).

    Description of Event or Problem · 1

    PATIENT COMPLICATIONS: (B)(6) YR. OLD MALE-PATIENT WITH NON-UNION. (MIPO TECHNIQUE). 4-PATIENTS WITH SKIN NUMBNESS (OPEN PLATING TECHNIQUE). (B)(4) YR. OLD MALE-PATIENT IMPLANT FAILURE DEVELOPED PLATE BREAKAGE (MIPO TECHNIQUE). (B)(4) YR. OLD MALE-PATIENT IMPLANT FAILURE WITH SCREW LOOSENING (OPEN PLATING TECHNIQUE). 3-PATIENTS SKIN IRRITATION OR DISCOMFORT DUE TO PLATE PROMINENCE (OPEN PLATING TECHNIQUE). 2-PATIENTS WITH SKIN IRRITATION OR DISCOMFORT DUE TO PLATE PROMINENCE (MIPO TECHNIQUE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561166 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention