BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP CLAVICLE PLATE/SCREWS

    MDR report key: 16070342 · Received December 29, 2022

    Report

    Report Number
    8030965-2022-11657
    Event Type
    Injury
    Date Received
    December 29, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: 3.5 MM LCP CLAVICLE PLATE/SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER FACILITY NAME: (B)(6) GERMANY. 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

    THIS REPORT INVOLVES ONE UNK - CONSTRUCTS: LCP CLAVICLE PLATE/SCREWS.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: NOLTE, P.C. ET AL (2021), NO DIFFERENCE IN MID TERM OUTCOME AFTER SUPERIOR VS. ANTEROINFERIOR PLATE POSITION FOR DISPLACED MIDSHAFT CLAVICLE FRACTURES, SCIENTIFIC REPORTS, VOL. 11 (22101), PAGES 1-8 (GERMANY). THE PURPOSES OF THIS RETROSPECTIVE COHORT STUDY WERE TO COMPARE OUTCOMES, COMPLICATIONS, REVISIONS, AND RATES OF IMPLANT REMOVAL OF SUPERIOR COMPARED TO ANTEROINFERIOR PLATING IN DISPLACED MIDSHAFT CLAVICLE FRACTURES AT MID-TERM FOLLOW-UP. BETWEEN MAY 2009 AND NOVEMBER 2014, A TOTAL OF 79 PATIENTS (63 MALE AND 16 FEMALE) WITH MEAN AGE OF 48.5 ± 13.0 YEARS WHO UNDERWENT OPERATIVE TREATMENT FOR DISPLACED MIDSHAFT CLAVICLE FRACTURES (GROUP A: 28 PATIENTS WITH SUPERIOR PLATING; GROUP B: 51 PATIENTS WITH ANTEROINFERIOR PLATING) WERE INCLUDED IN THE STUDY. SURGERY WAS PERFORMED USING LOCKING COMPRESSION PLATE (LCP, DEPUY SYNTHES, MA, USA) FOR BOTH GROUPS. TIME TO FOLLOW-UP DIFFERED SIGNIFICANTLY BETWEEN GROUPS (GROUP A: 5.7 (4.7¿7.1) YEARS VS. GROUP B: 4.3 (3.0¿5.9) YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: GROUP A - SUPERIOR PLATING: 60.7% OF PATIENTS UNDERWENT IMPLANT REMOVAL. A 51-YEAR-OLD MALE PATIENT SUFFERED REFRACTURE SHORTLY AFTER IMPLANT REMOVAL IN THE ABSENCE OF EXCESSIVE TRAUMA AND WAS REVISED 755 DAYS FOLLOWING THE PRIMARY SURGERY. 13 PATIENTS HAD PLATE-RELATED COMPLICATIONS: PAIN (N=2), PARESTHESIA (N=4), INFECTION (N=1), IMPLANT FAILURE (N=2), SOFT-TISSUE COMPROMISE (N=1), REFRACTURE AFTER IMPLANT REMOVAL (N=1), HEMATOMA (N=2). 7 PATIENTS UNDERWENT REVISION SURGERY: RE-OSTEOSYNTHESIS AND ILIAC CREST AUTOGRAFT (N=1), RE-OSTEOSYNTHESIS (N=2), SUPERFICIAL WOUND REVISION (N=1), HEMOSTASIS (N=2), DEEP WOUND REVISION (N=1). GROUP B - ANTEROINFERIOR PLATING: 66.7% OF PATIENTS UNDERWENT IMPLANT REMOVAL. A 40-YEAR-OLD MALE PATIENT HAD A NON-UNION AND WAS REVISED 412 DAYS AFTER PRIMARY SURGERY. A 57-YEAR-OLD PATIENT SUFFERED REFRACTURE SHORTLY AFTER IMPLANT REMOVAL IN THE ABSENCE OF EXCESSIVE TRAUMA AND WAS REVISED 380 DAYS FOLLOWING THE PRIMARY SURGERY. 16 PATIENTS HAD PLATE-RELATED COMPLICATIONS: PAIN (N=7), PARESTHESIA (N=2), INFECTION (N=2), IMPLANT FAILURE (N=1), SOFT-TISSUE COMPROMISE (N=1), REFRACTURE AFTER IMPLANT REMOVAL (N=1), EXOSTOSIS (N=1), NONUNION (N=1). 5 PATIENTS UNDERWENT REVISION SURGERY: RE-OSTEOSYNTHESIS AND ILIAC CREST AUTOGRAFT (N=2), RE-OSTEOSYNTHESIS (N=1), SUPERFICIAL WOUND REVISION (N=1), DEBRIDEMENT OF EXOSTOSIS (N=1). THIS REPORT INVOLVES ONE UNK - CONSTRUCTS: 3.5 MM LCP CLAVICLE PLATE/SCREWS. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2766376 UNK - CONSTRUCTS: LCP CLAVICLE PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention