BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: CLAVICLE PLATE/SCREWS

    MDR report key: 20817832 · Received December 2, 2024

    Report

    Report Number
    8030965-2024-14473
    Event Type
    Injury
    Date Received
    December 2, 2024
    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

    PRODUCT COMPLAINT # (B)(4). 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. H6 INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. 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

    THIS COMPLAINT IS FROM A LITERATURE. LIU ZQ, ZHANG MS, ZHOU ZF, ZHANG L, ZHENG LP. COMPARATIVE STUDY OF THREE DIFFERENT FIXATION TECHNIQUES FOR THE TREATMENT OF NEER TYPE IIB DISTAL CLAVICLE FRACTURES: A RETROSPECTIVE COHORT STUDY. FRONT SURG. 2023 FEB 6;10:1100720. DOI: 10.3389/FSURG.2023.1100720. PMID: 36814860; PMCID: PMC9939463. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY COMPARED THE OUTCOMES OF THE LOCKING PLATE COMBINED WITH A SUTURE BUTTON TO THE HOOK PLATE AND LOCKING PLATE METHODS IN THE TREATMENT OF DISTAL CLAVICLE NEER TYPE IIB FRACTURES, IN ORDER TO PROVIDE A BETTER UNDERSTANDING AND SURGICAL OPTIONS FOR NEER TYPE IIB FRACTURES. BETWEEN MARCH 2014 AND AUGUST 2019, A TOTAL OF 53 PATIENTS WITH NEER TYPE IIB DISTAL CLAVICLE FRACTURES WHO WERE TREATED WITH A HOOK PLATE (HP GROUP, 16 PATIENTS), A LOCKING PLATE ALONE (LP GROUP, 18 PATIENTS), OR A LOCKING PLATE WITH A SUTURE BUTTON (LPSB GROUP, 19 PATIENTS) IN OUR HOSPITAL. THE FOLLOW-UP PERIOD WAS AT LEAST 2 YEARS FOR ALL PATIENTS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: CLAVICLE HOOK PLATE/SCREWS (QTY 4). -HP GROUP, CLAVICLE SHAFT FRACTURES AND DISLOCATION OF THE HOOK OCCURED IN ONE PATIENT EACH. THE PATIENT WITH CLAVICLE SHAFT FRACTURES UNDERWENT REVISION SURGERY USING THE LONGER CLAVICULAR HOOK PLATE, AND THE PATIENT WITH DISLOCATION WAS TREATED WITH LPSB. THESE TWO PATIENTS UNDERWENT COMPLETE REVISION AND ACHIEVED UNION FINALLY. -2 PATIENTS WHO HAD SYMPTOMS OF PAIN IN THE FINAL FOLLOW-UP DEVELOPED ACROMION EROSIONS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: CLAVICLE PLATE/SCREWS (QTY 2). -IN THE LP GROUP, ACROMIOCLAVICULAR JOINT DISLOCATION (ROCKWOOD GRADE-III) AND DISTAL SCREW EXTRACTION OCCURRED IN TWO PATIENTS AND ONE PATIENT, RESPECTIVELY. THE PATIENTS WITH ACROMIOCLAVICULAR JOINT DISLOCATION WERE IMMOBILIZED WITH A SLING FOR 6 WEEKS. REVISION SURGERY WAS PERFORMED ON THE PATIENT WITH DISTAL SCREW EXTRACTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PLATES: LCP CLAVICLE HOOK PLATE (QTY 2). -HP GROUP, CLAVICLE SHAFT FRACTURES AND DISLOCATION OF THE HOOK OCCURED IN ONE PATIENT EACH. THE PATIENT WITH CLAVICLE SHAFT FRACTURES UNDERWENT REVISION SURGERY USING THE LONGER CLAVICULAR HOOK PLATE, AND THE PATIENT WITH DISLOCATION WAS TREATED WITH LPSB. THESE TWO PATIENTS UNDERWENT COMPLETE REVISION AND ACHIEVED UNION FINALLY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: LOCKING: LCP CLAVICLE PLATE (QTY 2). -IN THE LP GROUP, ACROMIOCLAVICULAR JOINT DISLOCATION (ROCKWOOD GRADE-III) AND DISTAL SCREW EXTRACTION OCCURRED IN TWO PATIENTS AND ONE PATIENT, RESPECTIVELY. THE PATIENTS WITH ACROMIOCLAVICULAR JOINT DISLOCATION WERE IMMOBILIZED WITH A SLING FOR 6 WEEKS. REVISION SURGERY WAS PERFORMED ON THE PATIENT WITH DISTAL SCREW EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303746 UNK - CONSTRUCTS: CLAVICLE PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention