BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 5219941 · Received November 12, 2015

    Report

    Report Number
    3004485144-2015-00094
    Event Type
    Injury
    Date Received
    November 12, 2015
    Date of Event
    November 2, 2015
    Report Date
    October 16, 2015
    Manufacturer
    BIOMET SPINE - BROOMFIELD
    Product Code
    KWQ
    PMA / PMN Number
    PK080646
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FOLLOW UP IT WAS IDENTIFIED THE BROKEN PORTIONS OF SCREWS WERE RETAINED BY THE PATIENT. THIS INFORMATION WAS NOT NOTED WHEN THE COMPLAINT WAS RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION. (B)(4). SUPPLEMENTAL REPORT THREE OF FOUR FOR THE SAME EVENT, REFERENCE 3004485144-2015-00081-1, 3004485144-2015-00082-1 AND 3004485144-2015-00095-1.

    Additional Manufacturer Narrative · 1

    TWO MAXAN 4.0MM X 14MM VARIABLE SCREWS, ITEM # 14-521614, LOT # J56515 WERE RETURNED FOR EVALUATION. THE COMPLAINT INDICATES THE SCREWS AND PLATE WERE IMPLANTED (B)(6) 2014, AND EXPLANTED DURING A REVISION SURGERY ON (B)(6) 2015 DUE TO BROKEN SCREWS AT C7. VISUAL INSPECTION OF THE SCREWS SHOW MINOR SCRATCHING AND WEAR AT THE SCREW HEADS CONSISTENT WITH NORMAL USE. NO FRACTURES OR OTHER ANOMALIES ARE NOTED. A FUNCTION CHECK OF THE RETURNED ITEM WAS NOT PERFORMED. THE DHR WAS REVIEWED AND NO NON-CONFORMANCES WERE NOTED. VISUAL EXAMINATION DOES NOT CONFIRM ANY REPORTED FAILURE. THE REPORTED COMPLAINT IS RELATED TO SCREW BREAKAGE, HOWEVER IT IS NOT RELATED TO THE TWO SCREWS OF THIS LOT NUMBER. SUPPLEMENTAL SUBMISSION THREE OF FOUR FOR THE SAME EVENT, REFERENCE 3004485144-2015-00081-2, 3004485144-2015-00082-2 AND 3004485144-2015-00095-2.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. REPORT THREE OF FOUR FOR THE SAME EVENT, SEE ALSO 3004485144-2015-00081, 3004485144-2015-00082 AND 3004485144-2015-00095.

    Description of Event or Problem · 1

    UPON FOLLOW UP IT WAS IDENTIFIED THE BROKEN PORTIONS OF SCREWS WERE RETAINED BY THE PATIENT.

    Description of Event or Problem · 1

    THE FACILITY REPORTED DURING THE PATIENT'S 12 MONTH REGULARLY SCHEDULED FOLLOW UP APPOINTMENT THEY IDENTIFIED BROKEN SCREWS AT THE 7TH CERVICAL (C7) VERTEBRA. A REVISION SURGERY WAS PERFORMED TO REMOVE INSTRUMENTATION AT LEVELS C5-7, ELONGATION, DEROTATION, FLEXION (EDF), ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) OF C4-5 AND REVISION ANTERIOR FUSION OF C5-7 WITH INSTRUMENTATION C4-7. THE ORIGINAL ACDF SURGERY WAS FOR C5-C7, BUT THE REVISION WAS COMPLETED ON C4-C7 LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750496 C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM MAXAN VARIABLE SCREW 4.0X14MM KWQ BIOMET SPINE - BROOMFIELD N/A J56515

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R