MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL X-POST SIZE 1 REFILL; POST, ROOT CANAL

Catalog Number 60667332

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2022

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 has been reported that x-post size 1 broke during use.All fragments were removed from patient's mouth.No injury to patient.

Manufacturer Narrative

Only unused x-posts size 1 were returned by the customer.The involved x-posts which broke were not returned and cannot be analyzed.Nothing unusual to report was found during dhr review.

• Brand Name: X-POST SIZE 1 REFILL
• Type of Device: POST, ROOT CANAL
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 13385131
• MDR Text Key: 286852588
• Report Number: 8031010-2022-00430
• Device Sequence Number: 1
• Product Code: ELR
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 60667332
• Device Lot Number: 1689977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/17/2022
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1