BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.9MM TI MATRIXRIB LOCKING SCREW

    MDR report key: 1513832 · Received October 20, 2009

    Report

    Report Number
    1719045-2009-00186
    Event Type
    Injury
    Date Received
    October 20, 2009
    Report Date
    September 21, 2009
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K081623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PATIENT SUSTAINED MULTIPLE RIB FRACTURES ON UNKNOWN DATE. IN 2009, SURGEON PERFORMED ORIF WITH 2.9MM TI MATRIXRIB LOCKING SCREWS AND TI MATRIXRIB PRE-CONTOURED PLATE ON RIB # 4, 5, AND 7 AND INTRAMEDULLARY SPLINTING OF RIB #6 (TI MATRIXRIB IM SPLINT PART # 04.501.011). OF NOTE, SURGEON CUT ONE TI MATRIXRIB PRE-CONTOURED PLATE (PART # 04.501.005) IN HALF AND UTILIZED IT FOR PLATING BOTH RIB 5 & RIB 7. REPORTEDLY, PATIENT DID NOT HEAL WELL AND WOUND VAC THERAPY WAS INITIATED ON AN UNKNOWN DATE. THE PATIENT ALSO EXPERIENCED THE FOLLOWING ISSUES: RIB 7 SCREW BACK OUT: THE 2.9MM TI MATRIX RIB LOCKING SCREW (PART # 04.502.022.01) BACKED OUT OF THE TI MATRIXRIB PRE-CONTOURED PLATE (PART # 04.501.005) AND EXTRUDED FROM THE INCISION. DATE OF OCCURRENCE IS UNKNOWN. THE HALVED PLATE AND 6 OF THE 7 SCREWS REMAIN IN THE PATIENT. RIB 6 SPLINT MIGRATION: ON POSTOP DAY #2 (TWO DAYS LATER), THE SPLINT WAS NOTED AS HAVING MIGRATED. CT SCANS TAKEN THREE MONTHS LATER, SHOWED THE SPLINT EXTRUDING FROM THE BONE ON THE POSTERIOR SIDE OF THE RIB. THE DEVICE ROTATED DOWN AND WAS PUSHING INTO THE DIAPHRAGM AND SPLEEN. SCREW WAS USED WITH SPLINT AND HAD A GOOD FIXATION IN THE CORRECT POSITION NOTED INTRAOP. UPON REMOVAL OF THE SPLINT, SURGEON NOTED FREE FLOATING BONE FRAGMENTS INSIDE THE CHEST CAVITY. RIB 5 BURSA FORMATION: BURSA NOTED ON CT SCAN TAKEN THE SAME DAY. PATIENT WAS RETURNED TO THE O.R. TWO DAYS LATER, FOR REMOVAL OF EXTRUDED SCREW (RIB 7), REMOVAL OF SPLINT (RIB 6), AND REMOVAL OF HALVED PLATE (RIB 5). THIS IS THE 2ND OF 4 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.9MM TI MATRIXRIB LOCKING SCREW MATRIXRIB LOCKING SCREW HWC SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention SPLINT| PLATE