BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 3025478 · Received March 28, 2013

    Report

    Report Number
    1030489-2013-00876
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 26, 2013
    Report Date
    April 23, 2013
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K994239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS RESULTS: "VISUAL AND OPTICAL EXAMINATION OF THE PLATE DISCOVERED ONE OF THE ANTI MIGRATION CAP TABS IS BROKEN OFF. THE BROKEN OFF PORTION OF THE TAB IS MISSING AND NOT RETURNED FOR ANALYSIS. THE LOCATION AND FRACTURE SURFACE MORPHOLOGY IS CONSISTENT WITH OVERLOAD DUE TO BONE SCREW BACK-OUT. DIMENSIONAL INSPECTION OF THE ANTI-MIGRATION FEATURE CONFIRMS MATERIAL THICKNESS TO BE WITHIN PRINT SPECIFICATION. DAMAGE AND SMEARING IS NOTED ON THE FRACTURE SURFACE. MICROSCOPIC EXAMINATION OF UNDAMAGED PORTIONS OF THE FRACTURE SURFACE PROVIDED SOME EVIDENCE OF A QUASI-BRITTLE FRACTURE, WITH NO INDICATION OF FATIGUE. 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

    (B)(4): RADIOLOGY FILMS INTERPRETATION "SINGLE LATERAL X-RAY VIEW OF PLATE WITH SCREWS AT C5 AND T1. INTERVENING CORPECTOMY WITH BONY GRAFT APPEARS TO SPAN C5/6-C7/T1. P LATE HAS PARTIALLY LIFTED OFF OF ANTERIOR CORTEX AND LOWER SCREWS HAVE BACKED OUT." SELF-TAPPING SCREWS OF MULTIPLE PART/LOT NUMBERS WERE ALSO IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 8792113 / LOT: UNK PART: 8792115 / LOT: UNK PART: 8792913 / LOT: UNK PART: 8792915 / LOT: UNK. ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT INITIALLY UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT C5-T1. POST-OPERATIVELY, ONE SCREW BACKED OUT OF THE PLATE REPORTEDLY DUE TO A SMALL PIECE OF THE LOCKING TAB BREAKING OFF. THIS WAS DISCOVERED AFTER X-RAYS WERE REVIEWED DURING A ROUTINE VISIT APPROXIMATELY FOUR YEARS POST-OP. THE DEVICES WERE EXPLANTED ONE MONTH LATER. IT IS REPORTED THAT FUSION DID OCCUR AND THAT NO FRAGMENTS ARE REMAINING IN PATIENT. NO FURTHER PATIENT COMPLICATIONS ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129106 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWP WARSAW ORTHOPEDIC, INC. NA W07C0018

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention 3.5X13, 3.5X15, 4.0X13, 4.0X15MM SELF-TAP SCREWS