BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7364187 · Received March 22, 2018

    Report

    Report Number
    2939274-2018-51188
    Event Type
    Injury
    Date Received
    March 22, 2018
    Report Date
    February 22, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE 411 PATIENTS ALL WITH SOME TYPE OF RIB FRACTURE; PATIENT'S INFORMATION NOT AVAILABLE FOR REPORTING. DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN PLATES: MATRIXRIB/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT & EXPLANT DATES ARE 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. 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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. [(B)(4) MAJERCIK 2015.PDF]

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE MAJERCIK S., VIJAYAKUMAR S., OLSEN G., WILSON E., GARDNER S., GRANGER S.R., VAN BOERUM D.H., WHITE T.W. (2015) SURGICAL STABILIZATION OF SEVERE RIB FRACTURES DECREASES INCIDENCE OF RETAINED HEMOTHORAX AND EMPYEMA. THE AMERICAN JOURNAL OF SURGERY. 210, PP. 1112-1117. UNITED STATES. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE TRUTH BEHIND THE AUTHORS PURPOSED HYPOTHESIZE, THAT PATIENTS WHO HAVE SURGICAL FIXATION OF RIB FRACTURES (SSRF) HAVE LESS RH AND EMPYEMA THAN THOSE WHO HAVE MEDICAL MANAGEMENT OF RIB FRACTURES (MMRF). THE STUDY INCLUDED 411 PATIENTS ALL WITH SOME TYPE OF RIB FRACTURE. THESE PATIENTS WERE SPLIT INTO TWO GROUPS DEPENDING ON THEIR TREATMENT TYPE, 137 OF THE 411 BELONGED TO THE SSRF GROUP AND THE REMAINING 274 BELONGED TO THE MMRF GROUP. BOTH GROUPS WERE SIMILAR WITH REGARD TO AGE, SEX, HEAD AIS, CHEST AIS, INJURY SEVERITY SCORE, AND INTENSIVE CARE UNIT AND HOSPITAL LENGTH OF STAY. SSRF SUBJECTS HAD MORE RIB FRACTURES THAN MMRF AND WERE IMPLANTED WITH THE MATRIXRIB (DEPUY SYNTHES, WEST CHESTER, PENNSYLVANIA). IT IS ONLY STATED THAT THE SSRF GROUP WERE IMPLANTED WITH THE SYNTHES DEVICE. THREE (3) PATIENTS IN THE SSRF GROUP REQUIRED A SIMPLE DRAINAGE PROCEDURAL INTERVENTION. IN ADDITION, ALL SSRF SUBJECTS HAD TUBE THORACOTOMIES PLACED AT THE TIME OF ADMISSION DUE TO HEMOTHORAX. IT IS UNCLEAR IF THE SYNTHES DEVICE WAS PRESENT IN THE PATIENT WHEN THE TUBE WAS IMPLANTED AND HEMOTHORAX DISCOVERED. THIS COMPLAINT INVOLVES A UNKNOWN MATRIXRIB 1 FOR 3 PATIENTS REQUIRING A SIMPLE DRAINAGE PROCEDURE AND 137 PATIENTS HAVING HEMOTHORAX. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206779 PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention