BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS-CHEST WALL

    MDR report key: 12685648 · Received October 22, 2021

    Report

    Report Number
    8030965-2021-08919
    Event Type
    Injury
    Date Received
    October 22, 2021
    Report Date
    September 27, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS FOR AN UNK - CONSTRUCTS: PLATE/SCREWS-CHEST WALL/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: HIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BAILLOT, R. ET AL. (2010), IMPACT OF DEEP STERNAL WOUND INFECTION MANAGEMENT WITH VACUUM-ASSISTED CLOSURE THERAPY FOLLOWED BY STERNAL OSTEOSYNTHESIS: A 15-YEAR REVIEW OF 23 499 STERNOTOMIES, EUROPEAN JOURNAL OF CARDIOTHORACIC SURGERY, VOL. 37, PAGES 880¿887 (B)(6). THIS STUDY WAS UNDERTAKEN TO EXAMINE THE OUTCOME OF PATIENTS WITH DEEP STERNAL WOUND INFECTION (DSWI) NOW TREATED WITH VACUUM-ASSISTED CLOSURE (VAC) THERAPY AS A BRIDGE TO STERNAL OSTEOSYNTHESIS WITH HORIZONTAL TITANIUM PLATE FIXATION. FROM JANUARY 2002 TO DECEMBER 2007, 149 PATIENTS UNDERWENT VAC USING THE SYNTHES TITANIUM HORIZONTAL PLATE FIXATION SYSTEM FOR DSWI. THE FOLLOWING COMPLICATIONS WERE REPORTED: EARLY ADJUSTED HOSPITAL MORTALITY FOR DSWI PATIENTS WAS 10.25% FOR THE ENTIRE PERIOD UNDER STUDY, WITHOUT SIGNIFICANT DIFFERENCES BETWEEN GROUPS TREATED IN THE EARLIER AND LATER PERIODS 9 PATIENTS HAD DSWI RECURRENCES AS A RESULT OF PERSISTENT OR RECURRENT INFECTION. THREE OF THEM WERE PREOPERATIVE MRSA CARRIERS. IN THESE PATIENTS, THE INFECTIOUS PROCESS WAS MOSTLY WELL-CIRCUMSCRIBED AND INVOLVED A CARTILAGE. APPROPRIATE ANTI-BIOTHERAPY AND COMPLETE HARDWARE REMOVAL ALONG WITH COSTOCHONDRAL DEBRIDEMENT RESULTED IN THE PRESERVATION OF CHEST-WALL INTEGRITY AND SURVIVAL IN ALL PATIENTS. THIS REPORT IS FOR AN UNKNOWN SYNTHES TITANIUM HORIZONTAL PLATE FIXATION SYSTEM. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR 1 UNK - CONSTRUCTS: PLATE/SCREWS-CHEST WALL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579614 UNK - CONSTRUCTS: PLATE/SCREWS-CHEST WALL PLATE, FIXATION ,BONE    HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention