BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTERPIECE PLATE FIXATION SYSTEM

    MDR report key: 6783894 · Received August 10, 2017

    Report

    Report Number
    1030489-2017-01906
    Event Type
    Injury
    Date Received
    August 10, 2017
    Report Date
    July 19, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NQW
    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, LOT, SIMILAR DEVICE, 510K#, UPN. G9010000252, 0560102W (X1) , 853-012, K050082, (B)(4). G9010000252, 0560104W (X2), 853-012, K050082, (B)(4). G9010000258 0491227W (X1), 853-012, K050082, (B)(4). G9010000274 , 0563443W (X6), 853-465 , K050082, (B)(4). G9010000275, 0555560W (X3), 853-467, K050082, (B)(4). G9010000275 , 0556341W (X2), 853-467, K050082 , (B)(4). ALTHOUGH IT IS UNKNOWN IF ANY OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. H6: PATIENT CODE C64343 (REVISION SURGERY). 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.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: CERVICAL SPONDYLOTIC MYELOPATHY PROCEDURE: LAMINOPLASTY LEVELS IMPLANTED: C4-C7 IT WAS REPORTED THAT ON UNKNOWN DATE, POST-OP, THE PATIENT SUFFERED WITH QUADRIPLEGIA AFTER SURGERY. QUADRIPLEGIA STARTED ON (B)(6) 2017. REVISION SURGERY WAS PERFORMED TO REMOVE THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566292 CENTERPIECE PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R