BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3875380 · Received June 16, 2014

    Report

    Report Number
    2520274-2014-11686
    Event Type
    Injury
    Date Received
    June 16, 2014
    Report Date
    June 3, 2014
    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 FOR TREATMENT, NOT DIAGNOSIS. RUSIMOV, V. L. (2014). TREATMENT OF UNSTABLE OSTEOPOROTIC FRACTURES OF PROXIMAL HUMERUS WITH LOCKING PLATES. OSTEOPOROSIS INT. 25(SUPPL 2), S160. THIS REPORT IS FOR AN UNKNOWN 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE. RUSIMOV, V. L. (2014). TREATMENT OF UNSTABLE OSTEOPOROTIC FRACTURES OF PROXIMAL HUMERUS WITH LOCKING PLATES. OSTEOPOROSIS INT. 25 (SUPPL 2), S160. ALMOST 20% OF THE PROXIMAL HUMERAL FRACTURES ARE UNSTABLE WITH ABSOLUTE INDICATIONS FOR SURGICAL TREATMENT. GOOD POSTOPERATIVE RESULT REQUIRES SURGICAL TECHNIQUE, WHICH MAINTAINS LOCAL BLOOD SUPPLY, WITH GOOD REDUCTION AND STABLE FIXATION AND ABILITY FOR EARLY REHABILITATION. THE PERSISTING OSTEOPOROSIS IS CHALLENGING FOR TREATMENT CHOICE AND EXPECTED RESULTS. LOW PROFILE LOCKING PROXIMAL HUMERUS PLATES (PHLP AND S3) GIVE GOOD OPPORTUNITY FOR REALIZING OF THESE CONDITIONS. THE AIM OF THIS REPORT IS TO REPRESENT THE OPINION AND RESULTS OF USING PROXIMAL HUMERUS LOCKING PLATES IN CASES WITH MODERATE TO SEVERE OSTEOPOROSIS. FROM 2005-2010, 23 PATIENTS WERE OPERATED ON (18 FEMALES AND 5 MALES) WITH AN AVERAGE AGE OF 71. FRACTURE DISTRIBUTION WAS ACCORDING TO AO. OPEN REDUCTION AND INTERNAL FIXATION VIA DELTOPECTORAL APPROACH WAS THE SURGICAL TECHNIQUE USED. THERE WAS SOFT TISSUE PRESERVATION. STABLE FIXATION WITH LOCKING PLATES 10 TYPE S3 (DEPUY) AND 13 TYPE LPHP (SYNTHES) WERE USED. DURING A 3 YEAR FOLLOW UP, 14 PATIENTS HAD EXCELLENT/GOOD RESULTS, 2 PATIENTS HAS POOR RESULTS AND 2 PATIENTS HAD AVASCULAR NECROSIS (AVN). THERE WERE NO INDICATIONS OF INFECTION OR NEUROVASCULAR COMPLICATIONS. THERE WERE 2 STABLE FIXATION WITH LOCKING PLATES 10 TYPE S3 (DEPUY) AND 13 TYPE LPHP (SYNTHES) USED IN THIS STUDY. THERE IS NO ALLEGATION OF A COMPLAINT AGAINST THIS DEVICE, THERE IS NO REPORTED MALFUNCTION OR ADVERSE EVENT CAUSED OR CONTRIBUTED TO THIS DEVICE. THE DEVICE FUNCTIONED AS INTENDED. ACCORDING TO THE INFORMATION PROVIDED IN THE LITERATURE ARTICLE, THERE IS NO ALLEGATION AGAINST A SYNTHES DEVICE. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352973 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention