BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMESH

    MDR report key: 6259504 · Received January 18, 2017

    Report

    Report Number
    1030489-2017-00124
    Event Type
    Injury
    Date Received
    January 18, 2017
    Date of Event
    December 20, 2016
    Report Date
    December 23, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NQW
    UDI-DI
    00885074317458
    PMA / PMN Number
    K050082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 853010WM / LOT: 0463760W (X1) PART: 853010WM/ LOT: 0463700W (X1); PART: 853010WM/ LOT: 0438447W (X1); PART: 853010WM/ LOT: 0106859W (X1); PART: 853-467/ LOT: 0497212W (X7); PART: 853-469 / LOT: 0489775W (X9). ALTHOUGH IT IS UNKNOWN IF ANY OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT A SURGERY DUE TO OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT AND STENOSIS OF SPINAL CANAL. POST-OP, PATIENT HAD NECK PAIN, LIMB WEAKNESS AND 0 LOWER LIMB MUSCLE STRENGTH. DUE TO WHICH THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2016 IN WHICH POSTERIOR CERVICAL DECOMPRESSION WITH VERTEX INTERNAL FIXATION WAS PERFORMED. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. PATIENT WAS ALSO REPORTED WITH BLEEDING "AFTER THE SURGERY." AFTER REVISION SURGERY PATIENT HAD NECK PAIN RELIEF BUT 0 LOWER LIMB MUSCLE STRENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45281 TIMESH ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS NA 0463760W 00885074317458

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention