MAUDE Adverse Event Report: COLTENE WHALEDENT INC. PARAPOST FIBER WHITE INTRO KIT; POST, ROOT CANAL

Catalog Number PF160

Device Problem Break (1069)

Patient Problem Tooth Fracture (2428)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

Customer complaint: customer states the fiber white post broke in half.The procedure was performed (b)(6) 2019 and the break (b)(6) 2021.Investigation: no batch information was provided by the customer and the label has been removed from the outside of the box.As no batch information is available, complaint analysis was performed dating back to january 1, 2013 to review all sap complaint records.A complaint for broken fiber posts was issued in may 2019 and was deemed improper use of product as the practitioner failed to follow the ifu.This complaint is the only complaint for this kit and failure mode.The customer has returned a fiber white intro kit.Actual device (broken post) was not returned.The returned kit contained the following items: one of each drill, 4 size 4.5 fiber white posts, 1 size 5 fiber white post, 1 size 5 fiber clear post, 3 size 5.5 fiber white posts, 1 5.5 fiber clear post, 1 size 6 fiber white post.The artwork label on the outside of the box is 81670 rev c.Based on the revision history table for this artwork, rev c was active from 01-02-2004 to 05-04-04 therefore this kit was manufactured most likely during this time frame.Root cause: as noted in 90693-010, possible root causes of this complaint include: raw material that has degraded over time, reducing the functional integrity of the post.The post was mislabeled and was too small for the canal interview with the product manager indicated that a post breaking half and half is a sign of incorrect placement.A combination of selecting the correct post size, placing the post correctly, leakage in the restoration, and general forces exerted on the post over time can lead to a weakened post that can lead to premature failure.

Event Description

Dentist had a patient where the fiber white post broke in the mouth after he performed a root canal.The post broke almost to the gum line, and half of it is in the canal and the other half is in the post core and crown.The break did not split the root.The patient said he woke up and the post was already broken, so there was no injury.The procedure was done in (b)(6) 2019 and the break was (b)(6) 2021.

• Brand Name: PARAPOST FIBER WHITE INTRO KIT
• Type of Device: POST, ROOT CANAL
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 12333296
• MDR Text Key: 267024651
• Report Number: 2416455-2021-00003
• 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: health professional
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: PF160
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other