BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI ANTERIOR TENSION BAND PLATE

    MDR report key: 2980281 · Received February 22, 2013

    Report

    Report Number
    3003506883-2013-10015
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    February 1, 2005
    Manufacturer
    SYNTHES (USA) ELMIRA
    Product Code
    KWQ
    PMA / PMN Number
    K022791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO RECEIVED REGARDING DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PT PARTICIPATED IN A MULTI-CENTER STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATION DISC DISEASE BETWEEN L2 AND S1. PT WAS IMPLANTED WITH AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPACER AT LEVEL L3_L4 SIZE AND L4_L5 SIZE, PT WAS ALSO IMPLANTED WITH AN ATB PLATE AT SCREW_L3_L, SCREW_L3_R, SCREW_L4_L, SCREW_L4_R, SCREW_15_L, AND SCREW_15_R, WITH ATB PLATE (B)(4). PT HAD BEEN EXPERIENCING PAIN FOR 36 MONTHS. SURGERY DATE WAS (B)(6) 2005, AND POSTOPERATIVELY PT EXPERIENCED LEFT ILIAC VEIN TEAR AND DULL ACHE LEFT LUMBOSACRAL BUTTOCK AREA, REQUIRING HEMOSTASIS WAS OBTAINED WITH HORIZONTAL MATTRESS SUTURES OF 4-0 PROLENE. THIS COMPLAINT IS ON THE ATB PLATE (B)(4). THIS COMPLAINT IS 1 OF 7 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78920 TI ANTERIOR TENSION BAND PLATE KWQ SYNTHES (USA) ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention