BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 6562572 · Received May 12, 2017

    Report

    Report Number
    1030489-2017-01166
    Event Type
    Injury
    Date Received
    May 12, 2017
    Report Date
    April 17, 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 PART IS NOT APPROVED FOR MARKET IN THE U.S. HOWEVER A LIKE DEVICE WITH PART # 8293420, 510K# K031967 AND UPN# (B)(4) IS MARKETED IN THE U.S. (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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    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: STENOSIS PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION LEVELS: L4-5-S1 REASON FOR REVISION: CAGE BACKED OUT REVISION SURGERY: REPLACEMENT OF THE S1 BOTH SIDE SCREWS AND TAPPING THE BACKED OUT CAGE. IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST OP, CAGE PLACED AT L5 -S1 BACKED OUT AND SCREWS WERE LOOSE. LOWER LIMBS PAIN WAS OBSERVED. THE SCREWS WERE REPLACED AND TAPPING OF THE BACKED OUT CAGE WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346210 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R