BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACFIX ROD, UNKNOWN

    MDR report key: 9599413 · Received January 16, 2020

    Report

    Report Number
    3012447612-2020-00031
    Event Type
    Injury
    Date Received
    January 16, 2020
    Report Date
    September 13, 2020
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HSB
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. THE CATALOG AND LOT NUMBER FOR THIS SPECIFIC DEVICE WAS NOT PROVIDED. THEREFORE, THE DEVICE AND COMPLAINT HISTORY RECORD (DHR) REVIEW CANNOT BE PERFORMED IN THIS CASE. IT WAS REPORTED THAT A PATIENT CAN FEEL THE IMPLANTS POSTOPERATIVELY AND WILL UNDERGO A REVISION SURGERY TO REMOVE THE CONSTRUCT. NO PATIENT OR SURGICAL INFORMATION WAS PROVIDED. THE REPORTED COMPLAINT COULD NOT BE VERIFIED WITH THE INFORMATION PROVIDED BY THE CUSTOMER AND NO RETURN OF THE REPORTED PRODUCT . THE EXACT CAUSE OF THIS EVENT CAN'T BE DETERMINE WITH THE AVAILABLE INFORMATION. IF FURTHER INFORMATION IS MADE AVAILABLE TO THE MANUFACTURER, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT CAN FEEL THE IMPLANTS POSTOPERATIVELY AND WILL UNDERGO A REVISION SURGERY TO REMOVE THE CONSTRUCT. NO PATIENT OR SURGICAL INFORMATION WAS PROVIDED. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    TYPE OF THE DEVICE: COMMON DEVICE NAME: SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM OR END-TO-END AND SIDE-BY-SIDE CONNECTORS. TYPE OF DEVICE: DEVICE PRODUCT CODE: MNI OR NKB. PMA/510(K): K030087 OR K010563. 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 3012447612-2020-00030 TO 3012447612-2020-00032.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT CAN FEEL THE IMPLANTS POSTOPERATIVELY AND WILL UNDERGO A REVISION SURGERY TO REMOVE THE CONSTRUCT. NO PATIENT OR SURGICAL INFORMATION WAS PROVIDED. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62157 BACFIX ROD, UNKNOWN SEE H10 HSB ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R