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

Catalog Number C195C00000100

Device Problems Break (1069); Device Operates Differently Than Expected (2913); 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 event it was reported that a radix anker "have no thread - so they snap and do not hold anyway".No injury resulted.

Manufacturer Narrative

Nothing unusual to report was found during dhr review.The four returned radix-anker standard posts #1 have been entrusted to our laboratory team who has measured the main dimensions which define the threads.As results, the thread geometries are matching to the drawing.Moreover, the returned spiral drill which was used to realize the holes in which the posts are inserted has been checked.Device turns out to be not damaged and is matching to the drawing.No fault found.Product meets specs.

• Brand Name: RADIX ANKER
• Type of Device: POST, ROOT CANAL
• Manufacturer (Section D): DENTSPLY MAILLEFER; ballaigues ; SZ
• Manufacturer Contact: helen lewis ; susquehanna commerce ctr w.; 221 w. philadelphia st., ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 5021574
• MDR Text Key: 24396848
• Report Number: 8031010-2015-00033
• 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: C195C00000100
• 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