BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTERPIECE PLATE FIXATION SYSTEM

    MDR report key: 7275991 · Received February 16, 2018

    Report

    Report Number
    1030489-2018-00239
    Event Type
    Injury
    Date Received
    February 16, 2018
    Report Date
    December 23, 2020
    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 · 0

    PRODUCT ANALYSIS #257637764:G9010000274, LOT# 0567631W. VISUAL AND FUNCTIONAL INSPECTION DID NOT REVEAL ANY DAMAGED NOR DOES IT INDICATE ANY FUNCTIONAL ISSUES. FUNCTIONAL TEST WITH A SAMPLE SCREW DRIVER CONFIRMED THE SCREW WOULD ATTACH AND RELEASE WITHOUT ANY ISSUES. THE SCREW APPEARS TO FUNCTION AS INTENDED. NO FAULT FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN US BUT A SIMILAR DEVICE WITH CATALOG # 853-465, UDI# (B)(4) AND 510K# K050082 IS APPROVED FOR SALE IN US. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: (PRODUCT ID: (B)(4), LOT: 0567631W, QTY: 8). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: X-RAY REVIEW RESULT: C5-6 LAMINOPLASTY POST-OP X-RAY AND CT IMAGES WERE PROVIDED. THERE IS A FRACTURE OF THE NON INSTRUMENTED SIDE OF THE LAMINOPLASTY AND TO NOT SEE A SCREW IN THE SPINAL CORD ON THE PROVIDED IMAGES. LIKELY CAUSE OF HARDWARE FRACTURE IS PROGRESSION OF DEFORMITY IN THE CONSTRUCT WHERE FUSION IS NOT EXPECTED TO OCCUR. 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 LAMINOPLASTY AT C5-C6 DUE TO SPONDYLOTIC MYELOPATHY. POST-OP, THE HINGE (PATIENT'S BODY PART) SIDE OF BOTH C5 AND C6 FRACTURED AND AS A RESULT THE IMPLANTED SCREWS DROPPED INTO THE SPINAL CANAL. PATIENT UNDERWENT REVISION SURGERY FOR REMOVING THE SCREW AND ALSO UNDERWENT POSTERIOR SPINAL FUSION (PSF) SURGERY AT C4-C7 DUE TO KYPHOSIS PROGRESS. THERE WAS NO DEFECTS ON THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121869 CENTERPIECE PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS G9010000274 0567631W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R