BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEULOCK SCREW, UNKNOWN SIZE

    MDR report key: 9969509 · Received April 16, 2020

    Report

    Report Number
    3012447612-2020-00204
    Event Type
    Injury
    Date Received
    April 16, 2020
    Date of Event
    January 9, 2020
    Report Date
    September 17, 2020
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6 (METHOD, RESULTS, AND CONCLUSIONS). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. DEVICE(S) ARE USED FOR TREATMENT. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE CERVICAL HARDWARE AFTER COMPLAINING OF HOARSENESS AND DIFFICULTY SWALLOWING. THERE WAS NO FURTHER SURGICAL OR PATIENT INFORMATION PROVIDED. THIS IS REPORT TWO OF FIVE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    TYPE OF THE DEVICE: COMMON DEVICE NAME: EBI ANTERIOR CERVICAL PLATE SYSTEM OR EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM OR MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM. PMA/510(K) NUMBER: K001794 OR K010003 OR K023133. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REFERENCE REPORTS 3012447612-2020-00203 TO 3012447612-2020-00207.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE CERVICAL HARDWARE AFTER COMPLAINING OF HOARSENESS AND DIFFICULTY SWALLOWING. THERE WAS NO FURTHER SURGICAL OR PATIENT INFORMATION PROVIDED. THIS IS REPORT TWO OF FIVE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431050 VEULOCK SCREW, UNKNOWN SIZE SEE H10 KWQ ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| O| R