BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR® ANTERIOR CERVICAL SYSTEM

    MDR report key: 4555338 · Received February 27, 2015

    Report

    Report Number
    1030489-2015-00388
    Event Type
    Injury
    Date Received
    February 27, 2015
    Date of Event
    January 30, 2015
    Report Date
    May 19, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8799147, 510K # K994239 WAS CLEARED IN THE UNITED STATES. 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 ANTI-MIGRATION CAP TABS HAVE BEEN BROKEN OFF AWAY FROM THE PLATE. 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) IS CONSISTENT WITH IMPLANT BACK-OUT. DIMENSIONAL INSPECTION CONFIRMS MATERIAL THICKNESS TO BE WITHIN PRINT SPECIFICATION. MICROSCOPIC EXAMINATION IDENTIFIED SOME INDICATION OF BEACH MARKS ON A PORTION OF THE FRACTURE SURFACE, WHICH PROVIDE SOME EVIDENCE OF LOW CYCLE FATIGUE. SOME EVIDENCE OF VERTICAL STRIATIONS NOTED ON THE FRACTURE SURFACE SUGGEST THE DIRECTION OF MATERIAL MOVEMENT. CONCLUSION: WITNESS MARKS AND PLASTIC DEFORMATION NOTED ON BOTH THE ANTI-MIGRATION CAP AND BONE SCREW ARE CONSISTENT WITH BONE SCREW BACK-OUT RESULTING IN SUBSEQUENT OVERLOAD OF THE ANTI-MIGRATION CAP. DIMENSIONAL INSPECTION CONFIRMS MATERIAL THICKNESS OF THE BROKEN ANTI-MIGRATION 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT UNSPECIFIED SPINAL PROCEDURE AT THE APPROXIMATE LEVELS OF C5-C7 ON (B)(6) 2014. ON (B)(6) 2015, THE PATIENT PRESENTED WITH SYMPTOMS OF DISCOMFORT AND AN X-RAY REVEALED THAT ONE OF THE 4 SCREWS USED WAS BACKED OUT COMPLETELY. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER FACILITY FOR FURTHER INSPECTION SINCE DAMAGE OF ESOPHAGUS AND/OR RESPIRATORY TRACT WAS SUSPECTED. REVISION WAS PERFORMED AT MIDNIGHT. DURING THE REVISION, THE LOCKING MECHANISM OF THE PLATE LOCATED ON THE BACKED OUT SCREW WAS FOUND TO BE BROKEN AND THE FRAGMENT OF THE LOCKING MECHANISM WAS MISSING. DAMAGE OF ESOPHAGUS WAS OBSERVED. THE FRAGMENT OF THE LOCKING MECHANISM COULD NOT BE FOUND. THE DAMAGE WAS THEN SUTURED WITH SEVEN STITCHES. THE PLATE AND OTHER SCREWS WERE ALSO REMOVED. NO RESPIRATORY TRACT DAMAGE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138114 ZEPHIR® ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA 0041569W

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention SCREWS