BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7892141 · Received September 19, 2018

    Report

    Report Number
    2939274-2018-53880
    Event Type
    Injury
    Date Received
    September 19, 2018
    Report Date
    August 23, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN MATRIXRIB PLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANTED, EXPLANTED DATES: 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ALI-OSMAN F, ET AL (2018). GERIATRIC (G60) TRAUMA PATIENTS WITH SEVERE RIB FRACTURES: IS MUSCLE SPARING MINIMALLY INVASIVE THORACOTOMY RIB FIXATION SAFE AND DOES IT IMPROVE POST-OPERATIVE PULMONARY FUNCTION? THE AMERICAN JOURNAL OF SURGERY. VOLUME 216. PAGES 46-51. (USA). THIS STUDY AIMED TO DETERMINE AND COMPARE PULMONARY FUNCTION (PFT) BEFORE AND AFTER MINIMALLY INVASIVE THORACOTOMY RIB FIXATION (MSMIT-ORF) AMONG GERIATRIC (G60) TRAUMA PATIENTS WITH SEVERE RIB FRACTURES. BETWEEN MAY 2014 TO OCTOBER 2016, 64 G60 PATIENTS WITH SEVERE RIB FRACTURES WITH PFTS WHO UNDERWENT MSMIT-ORF WERE INCLUDED IN THE STUDY. THEIR RESULTS WERE THEN COMPARED TO 135 NON-OPERATIVELY MANAGED (NOM) PATIENTS. THE MSMIT-ORF TREATED PATIENTS CONSISTED OF 41 MALES AND 23 FEMALES WITH AN AGE RANGE OF 63-74 YEARS OLD. THESE PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES MATRIXRIB RIB FIXATION SYSTEM CONSISTING OF FLEXIBLE TITANIUM PRE-CONTOURED PLATES AND SCREWS . STANDARDIZED RIB FRACTURE PROTOCOL WAS FOLLOWED FOR THESE PATIENTS. BEDSIDE PULMONARY FUNCTION TESTS WERE OBTAINED AT PRE-OP, ON POST-OP DAY 2 AND POST-OP DAY 5 WHENEVER POSSIBLE. COMPLICATIONS WERE REPORTED AS FOLLOWS: ONE REPORTED PATIENT DEATH. FIVE PATIENTS HAD PNEUMONIA. ONE PATIENT HAD ABSCESS. ONE PATIENT HAD ATRIAL FIBRILLATION. ONE PATIENT HAD ARRHYTHMIA. ONE PATIENTS HAD PNEUMOTHORAX. SIX PATIENT HAD PLEURAL EFFUSION. THIS REPORT IS FOR AN UNKNOWN SYNTHES MATRIXRIB TITANIUM PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732890 PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention