MAUDE Adverse Event Report: DENTSPLY MAILLEFER RADIX ANKER; POST, ROOT CANAL

Catalog Number C195C0000100

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

While no serious injury resulted in this event, there has been a previous report received where breakage resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event 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 even it was reported that a radix anker "have no thread" so they snap and do not hold anyway." no injury resulted.

Manufacturer Narrative

The given batch number does not correspond with the involved product.Dhr cannot be reviewed.The returned radix-anker 1 post has been obviously used by the customer (fitting and then removing from the canal).As a consequence, the thread and the head have many marks.No measurement can be taken, actual readings would be representative.However, the returned post actually integrates a thread which seems visually in compliance with drawing.For information, the proper fitting of a radix post also relies on the quality of the hole which is previously performed by the customer.The hole can be tested with the gauge c0191 prior to insert the post.Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: RADIX ANKER
• Type of Device: POST, ROOT CANAL
• Manufacturer (Section D): DENTSPLY MAILLEFER; ballaigues ; SZ
• Manufacturer Contact: helen lewis ; susquehanna commerce center w.; 221 w. philadelphia st., ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 5021573
• MDR Text Key: 24393334
• Report Number: 8031010-2015-00034
• Device Sequence Number: 1
• Product Code: ELR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C195C0000100
• Device Lot Number: 1/1199979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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