BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 2883223 · Received December 21, 2012

    Report

    Report Number
    1030489-2012-02925
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 21, 2012
    Report Date
    February 5, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    K994239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RADIOLOGY FILMS INTERPRETATION: "SINGLE LATERAL VIEW CERVICAL SPINE WITH FUSION AND ACDF C4-C5-C6. SELF-TAPPING SCREWS WHICH ARE RELATIVEDLY SHORT ARE NOTED AT EACH LEVEL WITH A FREE SCREW NOTED SITTING PARALLEL TO THE PLATE. COLLAPSE OF THE CONSTRUCT IS NOTED WITH INPINGEMENT OF PLATE ON C3 AND RELATIVE LOSS OF CERVIAL LORDOSIS."

    Additional Manufacturer Narrative · 1

    (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

    PRODUCT ANALYSIS: VISUAL AND OPTICAL EXAMINATION OF THE PLATED DISCOVERED ONE OF THE ANTIMIGRATION CAP TABS ARE BENT AWAY FROM THE PLATE AND CRACKED. THE SISTER TAB ON THE SAME CAP IS BROKEN OFF. THE BROKEN OFF PORTION OF THE TAB IS MISSING AND NOT RETURNED FOR ANALYSIS. THE DIRECTION OF PLASTIC DEFORMATION OF THE TAB (UPWARD, AWAY FROM THE PLATE) AND WITNESS MARKS NOTED ON THE SURFACE OF THE CRACKED UNBROKEN TAB WHICH TOUCHES THE BONE SCREW HEADS IS CONSISTENT WITH IMPLANT BACK-OUT. WITNESS MARK NOTED ON THE OUTSIDE FACE TAB, ADJACENT TO BONE SCREW INTERFACE WITNESS MARKS ON THE BOTTOM SURFACE. DIMENSIONAL INSPECTION CONFIRMS MATERIAL THICKNESS TO BE WITHIN PRINT SPECIFICATION. MICROSCOPIC EXAMINATION IDENTIFIED BEACH MARKS ON A PORTION OF THE FRACTURE SURFACE, AND PROVIDE SOME EVIDENCE OF LOW CYCLE FATIGUE. VERTICAL STRIATIONS NOTED ON THE ADJACENT FRACTURE SURFACE SUGGEST THE DIRECTION OF MATERIAL MOVEMENT. WITNESS MARKS AND PLASTIC DEFORMATION NOTED ON BOTH THE ANTIMIGRATION CAP AND BONE SCREWS ARE CONSISTENT WITH BONE SCREW BACK-OUT RESULTING IN SUBSEQUENT OVERLOAD OF THE ANTIMIGRATION CAP. DIMENSIONAL INSPECTION CONFIRMS MATERIAL THICKNESS OF THE BROKEN ANTIMIGRATION CAP TO BE WITHIN PRINT SPECIFICATION. AFTER VISUAL, OPTICAL AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT COMPONENTS; UNABLE TO DETERMINE SPECIFIC ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACDF PROCEDURE WITH PLATE IMPLANTATION. DURING A ROUTINE FOLLOW UP, IT WAS DISCOVERED THAT A SCREW ON THE LEFT SIDE HAD BACKED OUT. A REVISION WAS DONE TO REMOVE THE PLATE AND SCREW. IT WAS NOTED DURING THE REVISION, THAT THE PLATE WAS BROKEN. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA 0006245W

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR