BIOMET MICROFIXATION TMJ SYSTEM LEFT NARROW MANDIBULAR COMPONENT 45 MM / 6 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problem
Failure of Implant (1924)
|
Event Type
Injury
|
Manufacturer Narrative
|
Zimmer biomet complaint (b)(4).Concomitant medical products: item # ni, lot # ni, unknown screw.Qty 2.Item # 24-6563, lot # 212970; tmj system left fossa component, small.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2023-00031, 0001032347-2023-00032; 0001032347-2023-00044.
|
|
Event Description
|
It was reported the patient underwent a tmj procedure.Subsequently the patient is being considered for a revision on the left side due to screws backing out.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Event Description
|
This follow up is being submitted to relay additional information.
|
|
Manufacturer Narrative
|
This report is being submitted to update additional information in section b4, b5, g3, g6, h1, h2, h6 and h10.Upon reassessment of the reported event based on additional information, this product did not cause or contribute to the reported event.This initial report submitted needs to be voided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|
|
|