BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI SYNEX II

    MDR report key: 1772184 · Received July 21, 2010

    Report

    Report Number
    MW5016824
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 21, 2010
    Manufacturer
    SYNTHES
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IN MOTOR VEHICLE COLLISION ON (B)(6) 2009, SUFFERING MULTI-SYSTEM TRAUMA TO INCLUDE L3 FRACTURE. UNDERWENT L3 CORPECTOMY, FIXATION AND FUSION (B)(6) 2009, WITH SYNEX II DEVICE AND TSLP SYSTEM BOTH FROM SYNTHES. SYNTHES ANNOUNCED CLASS I RECALL OF TI SYNEX II DEVICE IN (B)(6) 2009. PT HAD CONTINUED PAIN POST-OP THAT WORSENED IN (B)(6) OF 2010. RADIOGRAPHIC EVIDENCE OF DEVICE COLLAPSE SUSPECTED ON PLAIN FILM AND CONFIRMED ON CT. PT TAKEN BACK TO OPERATING ROOM FOR EXPLANT OF TI SYNEX II DEVICE. REPORT MADE TO MFR. SYNTHES AND DEVICE IS RETURNED TO SYNTHES FOR EVAL. DATES OF USE: (B)(6) 2009 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: TREATMENT OF UNSTABLE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI SYNEX II TI SYNEX II MQP SYNTHES UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Disability TSLP FIXATION SYSTEM FROM SYNTHES