BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PHILOS PLATE/SCREWS

    MDR report key: 16042446 · Received December 23, 2022

    Report

    Report Number
    8030965-2022-11479
    Event Type
    Injury
    Date Received
    December 23, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: 510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: PHILOS PLATE/SCREWS. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER FACILITY ADDRESS: (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YIYUAN Z., ET AL, (2018), MINIMALLY INVASIVE TREATMENT OF NEER TWO-PART SURGICAL NECK FRACTURES OF THE HUMERUS: PHILOS PLATE VERSUS MULTILOC NAIL, CHINESE JOURNAL OF TISSUE ENGINEERING RESEARCH (2018), VOL 22(19) 2981¿2987 (CHINA). THE AIM OF THIS RETROSPECTIVE STUDY IS TO EVALUATE THE CLINICAL EFFECTIVENESS OF PHILOS PLATE VERSUS MULTILOC INTRAMEDULLARY NAIL USING MINIMALLY INVASIVE TECHNIQUE OF NEER 2-PART SURGICAL NECK FRACTURES OF THE PROXIMAL HUMERUS. FROM FEBRUARY 2013 TO JUNE 2016, A TOTAL OF 21 PATIENTS WITH NEER 2-PART SURGICAL NECK FRACTURES OF THE PROXIMAL HUMERUS WERE INCLUDED IN THE STUDY. AMONG THESE, 10 PATIENTS (MALE AND FEMALE; MEAN AGE OF (56.10 +/- 6.02) YEARS (44-64 YEARS) WERE TREATED WITH PHILOS LOCKING PLATE (LOCKING PLATE GROUP) AND 11 PATIENTS (3 MALE AND 8 FEMALE; MEAN AGE OF (58.27 +/- 8.82) YEARS (43-73 YEARS) WERE TREATED WITH MULTILOC INTRAMEDULLARY NAIL (INTRAMEDULLARY NAIL GROUP). ALL PATIENTS WERE FOLLOWED UP FOR 12-36 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: PHILOS PLATE GROUP: 3 PATIENTS HAD MILD PAIN AFTER SURGERY, AND ALL HAD PAIN RELIEF AFTER ORAL ADMINISTRATION OF SELOXIFENE. MULTILOC INTRAMEDULLARY NAIL GROUP: 2 PATIENTS HAD MILD PAIN AFTER SURGERY, AND ALL HAD PAIN RELIEF AFTER ORAL ADMINISTRATION OF SELOXIFENE. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT INVOLVES ONE UNK - CONSTRUCTS: PHILOS PLATE/SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2782846 UNK - CONSTRUCTS: PHILOS PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention