BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: TITANIUM STERNAL FIXATION SYSTEM

    MDR report key: 22335371 · Received June 26, 2025

    Report

    Report Number
    8030965-2025-06401
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    February 18, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL MANUFACTURER NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    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. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. 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 SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TAVAND¿IS J, NOVYSEDLÁK R, POZNIAK J, ¿VORCOVÁ M, MO¿NA F, VAJTER J, OZANIAK STRÍ¿OVÁ Z, SUCHÁNEK V, ¿IMONEK J, VACHTENHEIM J JR, LISCHKE R. BILATERAL LUNG HERNIATION WITH PARENCHYMAL INFARCTION FOLLOWING CLAMSHELL THORACOTOMY FOR LOBAR LUNG TRANSPLANTATION: A CASE REPORT. J CARDIOTHORAC SURG. 2025 FEB 18;20(1):132. DOI: 10.1186/S13019-025-03361-6. PMID: 39966849; PMCID: PMC11834686. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY PRESENTS AS CASE OF A 50-YEAR-OLD FEMALE (BODY MASS INDEX, BMI 29 KG/M2) WITH PULMONARY FIBROSIS, RHEUMATOID ARTHRITIS, ASTHMA, ARTERIAL HYPERTENSION, AND DIABETES MELLITUS HAD BEEN HOSPITALIZED FOR ALMOST 44 DAYS AT DEPARTMENT OF PNEUMOLOGY DUE TO RESPIRATORY INFECTION WITH THE NEED OF HIGH FLOW NASAL OXYGEN (HFNO). GIVEN THE DISEASE PROGRESSION AND DECLINE IN LUNG FUNCTION, SHE WAS EVALUATED BY MULTIDISCIPLINARY TEAM AND SUBSEQUENTLY LISTED AS THE URGENT CANDIDATE FOR LUNG TRANSPLANTATION. THE PATIENT UNDERWENT BILATERAL LOBAR LUNG TRANSPLANTATION IN JANUARY 2023, FOLLOWING 24 DAYS ON THE WAITING LIST, WITH PERIOPERATIVE CENTRAL VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. STERNUM FIXATION WAS ACHIEVED USING THE SYNTHES® TITANIUM STERNAL FIXATION SYSTEM PLATE (DEPUY SYNTHES, ZUCHWIL, SWITZERLAND) SECURED WITH SEVEN SELF-TAPPING SCREWS (18 MM). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES TITANIUM STERNAL FIXATION SYSTEM PLATE OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: UNKNOWN NON-ABSORBABLE POLYESTER SUTURES, ETHICON VICRYL SUTURE, UNKNOWN STAPLER. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PLATES: TITANIUM STERNAL FIXATION SYSTEM (QTY 1) UNK - SCREWS: TITANIUM STERNAL FIXATION SYSTEM (QTY 7) POSTOPERATIVE COURSE WAS COMPLICATED BY RENAL INSUFFICIENCY (WITHOUT THE NEED FOR HEMODIALYSIS), SEPTIC EPISODES, ICU MYOPATHY, AND REPEATED BRONCHOSCOPY FOR AIRWAY CLEARANCE, FOLLOWED BY TRACHEOSTOMY PERFORMED THROUGH AN OPEN SURGICAL APPROACH. DUE TO A CONSTANT NAUSEA AND VOMITING, PERCUTANEOUS ENDOSCOPIC. GASTROSTOMY/JEJUNOSTOMY WAS UTILIZED TO ENSURE THE NUTRITIONAL SUPPORT AND PREVENTION OF ASPIRATION. OTHER COMPLICATIONS THAT AROSE DURING THE POST-TRANSPLANTATION PERIOD INCLUDED INFECTIONS AND COLONIZATION WITH MULTIDRUG-RESISTANT BACTERIA, SUCH AS PSEUDOMONAS AERUGINOSA, ENTEROBACTER CLOACAE PRODUCING EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL), AND KLEBSIELLA PNEUMONIAE ESBL, AS WELL AS CHOLECYSTITIS AND HEART FAILURE WITH REDUCED EJECTION FRACTION. ON THE POSTTRANSPLANT DAY (PTD) 18, WHILE THE PATIENT WAS STILL SEDATED AND MECHANICALLY VENTILATED, THE WORSENING CLINICAL CONDITION AND ELEVATED INFLAMMATORY PARAMETERS PROMPTED A CHEST CT, REVEALING HERNIATION OF SEGMENT 6 OF THE RIGHT LUNG (FIG. 1). AN URGENT REVISION WAS PERFORMED WITH A FINDING OF A FAILURE OF THE POSTERIOR PERICOSTAL SUTURE. THE PULMONARY PARENCHYMA WAS INFARCTED AND VENOUS CONGESTION WAS ALREADY PRESENT (FIG. 2). THEREFORE, STAPLER RESECTION OF THE ENTIRE PROTRUDING TISSUE (90×30 MM) WAS NECESSARY. ON THE PTD 32, INFLAMMATORY PARAMETERS INCREASED AGAIN, WITH THE DEVELOPMENT OF SEPTICAEMIA. A CHEST CT (FIGS. 3 AND 4), WHICH WAS DONE TWO DAYS AFTER THE OUTBURST OF SYMPTOMS, SHOWED HERNIATION OF THE LEFT LUNG. URGENT SURGICAL REVISION REVEALED TWO COMPLETELY LOOSENED POSTERIOR PERICOSTAL SUTURES AND A COMPLETELY DETACHED DISTAL END OF THE SYNTHES TITANIUM STERNAL FIXATION SYSTEM PLATE WITH THE MISSING ANTERIOR STERNAL CORTEX. THE PROTRUDING VITAL LUNG PARENCHYMA WAS REPOSITIONED WITHOUT THE NEED OF RESECTION AND THORACOTOMY CLOSED USING 5 PERICOSTAL SUTURES. STERNAL RE-OSTEOSYNTHESIS WAS PERFORMED WITH A TRIPLE STRATOS (MEDXPERT GMBH, ESCHBACH, DEUTSCHLAND) STERNAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1883523 UNK - PLATES: TITANIUM STERNAL FIXATION SYSTEM PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention