BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 6375338 · Received March 3, 2017

    Report

    Report Number
    1030489-2017-00446
    Event Type
    Injury
    Date Received
    March 3, 2017
    Date of Event
    February 6, 2017
    Report Date
    February 6, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    REFER 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 SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE # 6860137 AND 510K# K992110 AND UDI# (B)(4) IS APPROVED FOR SALE IN THE US. (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS: OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENTS (OPLL). FOR WHICH PATIENT UNDERWENT, ANTERIOR CERVICAL DECOMPRESSION FUSION AT LEVELS C4-6. REPORTEDLY, ON (B)(6) 2017, POST-OP, THE PLACED SPINAL PLATE AND SCREW BACKED OUT. THE SCREWS WERE INSERTED IN C4 AND C6. QUANTITY OF SCREW(S) WHICH BACKED OUT IS UNKNOWN. REVISION SURGERY IS SCHEDULED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158850 PREMIER® ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention