BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6536452 · Received May 2, 2017

    Report

    Report Number
    1030489-2017-01072
    Event Type
    Injury
    Date Received
    May 2, 2017
    Report Date
    April 6, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 55711015545/ LOT: CA13K070 (X1) PART: 55711016545/ LOT: CA15J034 (X1) PART: 1555106110/ LOT: 0430233W (X1) PART: 7078398/ LOT: H5337395 (X1) ALTHOUGH IT IS UNKNOWN IF ANY OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER LIKE DEVICE CATALOGS FOR PLI10 IS #55811015545, 510K #K122433, UDI # (B)(4); FOR PLI20 IS #55811016545, 510K #K122433, UDI # (B)(4); FOR PLI30 IS #1555006110, 510K #K121680, UDI # (B)(4) AND FOR PLI40 IS #5440030, 510K #K102555, UDI # (B)(4) WERE CLEARED IN THE UNITED STATES. (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. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT CORRECTION PROCEDURE FOR L1 BURST FRACTURE WITH SCREWS AND RODS IMPLANTATION. POSTOPERATIVELY, INFECTION WAS OBSERVED AT THE AREA OF ONE SIDE SCREW AND AROUND ROD BECAUSE AT THE TIME OF SURGERY FINAL TIGHTENING WAS PERFORMED WITH THE FASCIA AT ONLY ONE SIDE WAS SANDWICHED. THE SURGEON CONSIDERED THAT IT CAUSED THE DEAD SPACE BETWEEN SKIN AND FASCIA THEN INFECTION MIGHT HAVE OCCURRED. ON (B)(6) 2017, THE PATIENT UNDERWENT REVISION SURGERY. IN THE REVISION SURGERY, THE IMPLANTS AT LEFT SIDE WERE EXPLANTED, THE INFECTED AREAS WERE CLEANED AND ANTIBIOTIC WERE SPRAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317906 CD HORIZON SPINAL SYSTEM KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R