BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXRIB PRE-CONTOURED PL 18 HOLES FOR RIGHT RIBS 8 & 9

    MDR report key: 4730504 · Received April 27, 2015

    Report

    Report Number
    2520274-2015-13442
    Event Type
    Injury
    Date Received
    April 27, 2015
    Report Date
    April 20, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    PK133616
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    DATE OF PATIENT PAIN, INCOMPLETE HEALING, AND PLATE FRACTURE UNKNOWN. DEVICE HAS NOT BEEN REPORTED AS EXPLANTED. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT ON (B)(6) 2015 REPORTS THAT SHE WILL UNDERGO FURTHER EVALUATION AND POSSIBLE REVISION SURGERY. THE PATIENT ALSO PROVIDED A REPORT FROM A CT SCAN PERFORMED ON (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR STABILIZATION OF CHRONIC DISPLACED RIGHT RIB FRACTURES ON (B)(6) 2012 DUE TO A BLUNT CHEST TRAUMA WHICH TOOK PLACE IN (B)(6) OF 2012 AND CAUSED MULTIPLE RIB FRACTURES. THE PATIENT UNDERWENT INTERNAL FIXATION OF RIGHT POSTEROLATERAL RIB FRACTURES INCLUDING THE SIXTH, SEVENTH, EIGHTH AND NINTH RIBS ON (B)(6) 2012. THE PATIENT DEVELOPED CHRONIC PERSISTENT PAIN AND DISPLACEMENT ON CT SCAN OF RIGHT RIB FRACTURES WAS NOTED. IT WAS NOTED THAT AT THE SIXTH RIB THERE WAS PARTIAL HEALING ON THE RIB FRACTURE AND THE FIXATION PLATE IS INTACT. AT THE SEVENTH RIB THERE IS INCOMPLETE HEALING AND THE FIXATION PLATE IS INTACT. AT THE EIGHTH RIB THERE IS INCOMPLETE BONY BRIDGING ACROSS THE EIGHTH RIB AND A PARTIAL FRACTURE OF THE FIXATION PLATE. AT THE NINTH RIB THERE IS INCOMPLETE HEALING, MILD DISPLACEMENT OF THE RIB FRACTURE AND THE FIXATION PLATE IS FRACTURED. THERE IS A HEALED RIB FRACTURE AT THE TENTH RIB. THERE ARE NO ACUTE RIB FRACTURE AND NO FOCAL BONY LESIONS. THERE IS PLEURAL THICKENING ALONG THE PLEURAL SURFACE UNDERLYING THE SEVENTH THROUGH NINTH RIBS, BUT THERE IS NO PERIPHERAL FLUID COLLECTION AROUND THE FIXATION HARDWARE AND NO ABNORMALITY OF THE OVERLYING MUSCULATURE OF THE CHEST WALL. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED: PATIENT HAD REVISION SURGERY TO REMOVE THE BROKEN MATRIX RIB PLATES IN (B)(6) 2015 AT (B)(6) TRAUMA CENTER (B)(6). THE PATIENT REPORTEDLY HAD TWO (2) NEW ONES IMPLANTED. PATIENT IS REPORTEDLY EXPERIENCING IMPROVEMENT IN PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276802 TI MATRIXRIB PRE-CONTOURED PL 18 HOLES FOR RIGHT RIBS 8 & 9 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention