MAUDE Adverse Event Report: DENTSPLY MAILLEFER PASTE FILLER; INSTRUMENT, FILLING, PLASTIC, DENTAL

Catalog Number S206100440101

Device Problems Break (1069); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where this malfunction 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 paste filler separated after initial use.The broken part was retrieved and there is no indication that injury resulted.

Manufacturer Narrative

Involved root fillers which were returned have been analyzed.One of them is actually broken at the base of the active part and no material defect was found during analysis of the rupture pattern.The second instrument is unscathed without visible marks of use.Nothing unusual to report was found during dhr review.No unused product have been returned for evaluation.Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: PASTE FILLER
• Type of Device: INSTRUMENT, FILLING, PLASTIC, DENTAL
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer (Section G): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6373761
• MDR Text Key: 69258446
• Report Number: 8031010-2017-00010
• Device Sequence Number: 1
• Product Code: EIY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S206100440101
• Device Lot Number: 1279419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1