MAUDE Adverse Event Report: DENTSPLY DETREY GMBH QUIXFIL POSTERIOR RESTORATIVE; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 60605606

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

In this event a dentist reported that after completing restoration with quixfil there were 5 fillings with associated strong postoperative biting pain.In two of the pts, root canal treatments were necessary.Three of the fillings were close to the pulp.

Manufacturer Narrative

It is unclear if these five fillings were in five separate pts or if they were five fillings between two different pts.Follow up attempts have not yet been successful in reaching the dentist for add'l info.Add'l attempts are scheduled.However, because medical intervention was required to preclude permanent impairment of a body function or permanent damage to a body structure, this event is reportable per 21 cfr part 803.Reports for the two known pts are being submitted.Should it be determined that three add'l pts were involved complaints for those pts will be initiated.This report is for the second pt.

• Brand Name: QUIXFIL POSTERIOR RESTORATIVE
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): DENTSPLY DETREY GMBH; konstanz ; GM
• Manufacturer Contact: helen lewis ; 221 w philadelphia st, ste 60; susquehanna commerce ctr w; york, PA 17401 ; 7178457511
• MDR Report Key: 4538423
• MDR Text Key: 5538266
• Report Number: 8010638-2015-00002
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K040144
• 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
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 60605606
• Device Lot Number: 1407000552
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DC DENTINE-COMPOSITE BONDING
• Patient Outcome(s): Required Intervention