BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5994906 · Received October 3, 2016

    Report

    Report Number
    2520274-2016-14773
    Event Type
    Injury
    Date Received
    October 3, 2016
    Report Date
    August 11, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. EXACT DATE OF SYMPTOM ONSET AND DEVICE BREAKAGE IS UNKNOWN. THIS REPORT IS FOR TWO (2) UNKNOWN MATRIX RIB PLATES. WITHOUT A VALID PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A VALID PART/LOT NUMBER, THE EXACT 510K NUMBER CANNOT BE CONFIRMED. HOWEVER, THE LIKELY VALUE IS K133616. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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

    IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE SURGEON'S OFFICE ON (B)(6) 2016 WITH THE COMPLAINT OF NEW PAIN. IT WAS REPORTED THAT AN X-RAY TAKEN IN THE SURGEON'S OFFICE SHOWED ONE OF THE MATRIX RIB PLATES THAT WAS IMPLANTED ON (B)(6) 2016 HAD A LOOSE SCREW, AND THE RIB WAS DISPLACED. A TREATMENT PLAN TO ADDRESS THIS ISSUE HAS NOT YET BEEN DETERMINED BY THE SURGEON. INITIALLY, THE PATIENT FELL AND SUSTAINED MULTIPLE RIB FRACTURES ON AN UNKNOWN DATE IN (B)(6) 2016. THE PATIENT WAS TREATED WITH PAIN MEDICATION. THE PATIENT RETURNED TO THE SURGEON ON AN UNKNOWN DATE IN (B)(6) 2016 COMPLAINING OF CONTINUED RIB PAIN AFTER HER INITIAL INJURY. X-RAYS AT THE TIME SHOWED NONUNION OF SEVERAL OF THE RIB FRACTURES. ON (B)(6) 2016 SURGERY WAS PERFORMED. A MATRIX RIB SET SYSTEM PLATE(S) AND AN UNKNOWN QUANTITY OF UNKNOWN SCREWS WERE IMPLANTED. ADDITIONAL CLARIFICATION: THE PATIENT WAS ORIGINALLY INJURED SOMETIME DURING (B)(6) 2016, WHEN THE SEVENTH, EIGHTH, NINTH, AND TENTH RIBS WERE FRACTURED. ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH A RIB PLATE AND EIGHT (8) MATRIX RIB SCREWS ON AN UNKNOWN LEFT RIB. FOLLOWING REPORTS OF PAIN AT THE IMPLANT SITE, THE PATIENT UNDERWENT X-RAY IMAGING ON (B)(6) 2016. THE IMAGES SEEMED TO INDICATE THAT ONE (1) OF THE SCREWS HAD LOOSENED FROM THE PLATE, WHICH, IN TURN, CAUSED THE PLATE TO MOVE AWAY FROM THE BONE RESULTING IN A NON-UNION. ON (B)(6) 2016, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR REVISION. DURING THE PROCEDURE, TWO (2) BROKEN PLATES AND AN UNKNOWN QUANTITY OF SCREWS WERE REMOVED. NON-UNION WAS ASSESSED AT TWO (2) OF THE RIBS. THE PATIENT WAS REVISED TO AN ILIAC BONE GRAFT ALONG WITH THE IMPLANTATION OF TWO (2) TITANIUM MATRIXRIB PLATES AND SIXTEEN (16) UNKNOWN SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF DELAY OR PATIENT HARM. CONCOMITANT DEVICE(S) REPORTED: SCREW (PART/LOT/QUANTITY: UNKNOWN) THIS REPORT IS FOR TWO (2) UNKNOWN MATRIX RIB PLATES. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646044 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention UNKNOWN MATRIX RIB SCREWS