BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTERPIECE PLATE FIXATION SYSTEM

    MDR report key: 6248732 · Received January 13, 2017

    Report

    Report Number
    1030489-2017-00085
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    December 17, 2016
    Report Date
    December 19, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NQW
    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: G9010000252 / LOT: UNK (X3) ALTHOUGH IT IS UNKNOWN IF ANY OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG #S 853-012, 853-467, AND 853-471 AND 510K # K050082 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. (B)(4).

    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 SURGERY. POST-OP, ON (B)(6) 2016, WHEN PATIENT VISITED FOR FOLLOW-UP, EXUDATE WAS OBSERVED FROM SURGICAL SITE. AS INFECTION WAS SUSPECTED, CLEANING OF THE SITE, REMOVAL OF THE IMPLANTS AND LAMINECTOMY WERE PERFORMED. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN. THE HOSPITAL CONSIDERED THAT THE INFECTION IS NOT RELATED WITH INTRAOPERATIVE FACTORS BECAUSE THE INFECTION WAS AFTER REMOVAL OF STITCHES. PATIENT'S DATE OF DISCHARGE IS UNCERTAIN BECAUSE OF WOUND CLEANING DUE TO INFECTION AND PERFORMING LAMINECTOMY. NO PRODUCT MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31725 CENTERPIECE PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention