BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRAMESH IMPLANT SYSTEM

    MDR report key: 6157487 · Received December 9, 2016

    Report

    Report Number
    1030489-2016-03386
    Event Type
    Injury
    Date Received
    December 9, 2016
    Report Date
    November 16, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    EZX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG NUMBER 905-320 AND 510K NUMBER K890601 IS APPROVED FOR SALE IN 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.

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW: POST-OP, PRE-REVISION X-RAYS PROVIDED AFTER C3-5 ANTERIOR STABILIZATION OF TRAUMATIC FRACTURE WITH C4 CORPECTOMY. THESE SHOW FAILURE OF THE CONSTRUCT WITH CAGE MIGRATION. PER COMMENTS STRUCTURES WERE DISRUPTED POSTERIORLY AND SOME DIFFICULTY WAS ENCOUNTERED WITH PLATE PLACEMENT AT INITIAL SURGERY. THIS SUGGEST THAT 360 DEGREE CONSTRUCT WOULD HAVE BEEN APPROPRIATE INITIALLY.

    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 C3/5 ANTERIOR CERVICAL DISKECTOMY AND FUSION (ACDF) AND POSTERIOR SPINAL FUSION. ON AN UNKNOWN DATE, POST-OP, ONE SCREW IN THE RIGHT SIDE OF CAUDAL PORTION BACKED OUT. IN ADDITION, THE SPINAL CAGE MIGRATED. THE DURA MATER WAS COMPRESSED BY THE CAGE AND NUMBNESS OF THE HAND HAD WORSENED (ON AN UNKNOWN DATE), THEREAFTER THE PATIENT UNDERWENT X-RAY ON (B)(6) 2016 WHICH REVEALED THAT THE IMPLANTS HAD DISLOCATED. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016. IN WHICH ALL THE IMPLANTS WERE REPLACED. THE PATIENT UNDERWENT SPINAL FUSION DUE TO TRAUMA. THE PATIENT HAD INSTABILITY IN POSTERIOR COMPONENTS INCLUDING FACET JOINT AND HAD POOR BONE. PLATE COULDN'T BE WELL SEATED ON THE BONE DUE TO ITS UNFAVORABLE SHAPE. ALL THE IMPLANTS WERE REMOVED. THERE WAS PROLONGATION OF HOSPITALIZATION DUE TO THE REVISION SURGERY AND THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE IN THE REVISION SURGERY. DOCTOR¿S COMMENT: "IT COULDN'T BE DETERMINED WHICH OCCURRED FIRST BACK-OUT OF SCREW OR CAGE MIGRATION. THE ROCK SCREW MAY HAVE NOT BEEN STEADILY TIGHTENED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809616 PYRAMESH IMPLANT SYSTEM MESH, METAL EZX WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention