MAUDE Adverse Event Report: RADIX ANKER CROSS CUT; POST, ROOT CANAL

Catalog Number C193T00000200

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that a radix anker post separated during use.The outcome of the event is unknown as of this mdr evaluation.

Manufacturer Narrative

The batch number is unknown, dhr cannot be reviewed.The two broken fragments of a radix anker post titanium 2 have been returned.First fragment (head) is stuck to the metallic crown and the second fragment (shank) is still screwed inside the extracted patient root.The customer also sent seven posts in loose which are unused.The broken fragments have been analyzed, breakage occurred at the base of the head.No material or machining defect was found during analysis of the rupture pattern.The unused posts have been evaluated.No material or machining defect was noted after observation and the items are dimensionally in compliance with current drawing.The root causes of the breakage are not identified.We will track this kind of event and monitor the trend.Multiple unsuccessful attempts were made to obtain the patient outcome.

• Brand Name: RADIX ANKER CROSS CUT
• Type of Device: POST, ROOT CANAL
• MDR Report Key: 12584990
• MDR Text Key: 276655851
• Report Number: 8031010-2021-00202
• Device Sequence Number: 1
• Product Code: ELR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C193T00000200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1