BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH

    MDR report key: 6562565 · Received May 12, 2017

    Report

    Report Number
    1030489-2017-01164
    Event Type
    Injury
    Date Received
    May 12, 2017
    Date of Event
    April 18, 2017
    Report Date
    April 18, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR USE IN THE US, HOWEVER, A LIKE DEVICE WITH PART # 8293540, 510K# K030285 AND UPN# (B)(4) HAS BEEN APPROVED FOR THE US MARKET. (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

    PRE-OP DIAGNOSIS: EXTENSION OF FIXATION RANGE TO T10 AND CURETTAGE AND WASHING OF THE INFECTED AREA PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION LEVELS: T10-L2 IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE ON (B)(6) 2016. POST-OP, INFECTION WAS DEVELOPED AND PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2017. DURING THE REVISION SURGERY, THE T11 SCREW WAS FOUND TO BE LOOSE. IT WAS REMOVED AND CURETTAGE AND WASHING OF THE INFECTED AREA WERE ALSO PERFORMED. THE SCREW WAS RE-USED AT T10 WHERE RE-FIXATION WAS CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346207 TSRH APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R