BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TITANIUM STERNAL FIXATION SYSTEM

    MDR report key: 12685598 · Received October 22, 2021

    Report

    Report Number
    8030965-2021-08918
    Event Type
    Injury
    Date Received
    October 22, 2021
    Report Date
    September 27, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNK - SCREWS: TITANIUM STERNAL FIXATION SYSTEM/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: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: PLASS, A. ET AL. (2008), TITANIUM PLATE OSTEOSYNTHESIS FOR THE CORRECTION OF SEVERE STERNAL DEFORMITY IN A (B)(6) YEAR-OLD BOY, INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY, VOL. 7, PAGES 935¿937 (SWITZERLAND). THIS STUDY PRESENTS A CASE REPORT OF A (B)(6) YEAR-OLD MALE PATIENT WHO DEVELOPED A MASSIVE STERNAL DEFORMITY AFTER ATRIOVENTRICULAR SEPTAL DEFECT (AVSD) CORRECTION AT THE AGE OF ONE YEAR AND MITRAL VALVE RECONSTRUCTION AT TWO YEARS. MITRAL VALVE RECONSTRUCTION WAS NECESSARY, AND THE PLAN WAS TO CORRECT HIS STERNAL DEFORMITY AT THE SAME TIME USING SPECIALLY DESIGNED TITANIUM PLATES (SYNTHES, SWITZERLAND). AFTER SIX MONTHS THE PLATES WERE STILL IN A GOOD POSITION, WHEREAS IN THE MANUBRIUM PLATE A SLIGHT LOOSENING OF TWO SCREWS WAS VISIBLE. ALSO, THE GAP WAS STILL VISIBLE WHEREAS THE REST OF THE STERNUM WAS WELL-SHAPED. BECAUSE OF THE COMPLETE CONSOLIDATION OF BONE REPAIR, IT WAS DECIDED TO REMOVE THE PLATES, WHICH WAS CARRIED OUT WITHOUT COMPLICATIONS. IN THE 8-MONTH FOLLOW-UP, THE BOY SHOWED NO DISCOMFORT WITHOUT RESTRICTION AND A VERY SATISFYING COSMETIC RESULT. THIS REPORT IS FOR UNKNOWN SYNTHES TITANIUM PLATES. THIS REPORT IS FOR ONE (1) UNK - SCREWS: TITANIUM STERNAL FIXATION SYSTEM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576805 UNK - SCREWS: TITANIUM STERNAL FIXATION SYSTEM SCREW,FIXATION,BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention