BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEK CAGE, UNKNOWN TYPE

    MDR report key: 11302474 · Received February 9, 2021

    Report

    Report Number
    3012447612-2021-00027
    Event Type
    Injury
    Date Received
    February 9, 2021
    Date of Event
    January 6, 2021
    Report Date
    April 6, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND INITIALLY CORRECTED INFORMATION. SUMMARY: THE COMPLAINT IS CONFIRMED FOR ONE (1) OF ONE (1) RETURNED PEEK CAGE (PN UNKNOWN) FOR THE FAILURE OF IMPLANT FRACTURED POST OPERATION. MEDICAL RECORDS WERE PROVIDED IN FORM OF X-RAYS. THE PROVIDED X-RAYS CONFIRMS THAT AN IMPLANT WAS MIGRATED. POTENTIAL CAUSE: DESPITE THE PRODUCTS WERE RETURNED FOR EVALUATION, ROOT CAUSE CAN'T BE ESTABLISHED. PATIENT CONDITIONS AND EVENTS PRIOR TO THE SURGERY ARE NOT KNOWN. INSUFFICIENT INFORMATION WAS PROVIDED. DHR REVIEW AND RELATED ACTIONS: PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. NO ACTIONS REQUIRED. THIS EVENT IS NOT RELATED TO ANY CURRENT ACTIONS OR RECALLS OR PRODUCT HOLDS. DEVICE USE : THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW FRACTURED AND BACKED OUT POST-OP, WHICH CAUSED THE CONSTRUCT TO BE UNSTABLE AND FUSION WAS NOT ACHIEVED. ADDITIONALLY, THE CAGE WAS FOUND TO BE CRACKED. A 2-LEVEL PLATE, 6 SCREWS, AND CAGE WERE REMOVED DURING A REVISION SURGERY. THIS IS REPORT EIGHT OF EIGHT FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT DEVICE CODE IS SIMILAR TO MAX. PMA/510(K) NUMBER: SIMILAR TO K082774. REFERENCE REPORTS 3012447612-2021-00020 THRU 3012447612-2021-00027. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW FRACTURED AND BACKED OUT POST-OP, WHICH CAUSED THE CONSTRUCT TO BE UNSTABLE AND FUSION WAS NOT ACHIEVED. ADDITIONALLY, THE CAGE WAS FOUND TO BE CRACKED. A 2-LEVEL PLATE, 6 SCREWS, AND CAGE WERE REMOVED DURING A REVISION SURGERY. THIS IS REPORT EIGHT OF EIGHT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199471 PEEK CAGE, UNKNOWN TYPE SIMILAR TO LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE MAX ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R