MAUDE Adverse Event Report: DENTSPLY DETREY GMBH AH PLUS ROOT CANAL SEALER; RESIN, ROOT CANAL FILLING

Catalog Number 60620110

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 07/13/2015

Event Type  Injury  

Manufacturer Narrative

Unset sealer can cause or contribute to acute periapical inflammation resulting in pain.Because this event required intervention, it meets the criteria for a reportable event per 21 cfr part 803.

Event Description

In this event it was reported that three days after treatment with ah plus, a patient experienced pain.Upon reopening the root canal, the dentist discovered that the ah plus was still soft and was able to remove the gutta-percha point.

• Brand Name: AH PLUS ROOT CANAL SEALER
• Type of Device: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz, 78467 ; GM 78467
• Manufacturer (Section G): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz, 78467 ; GM 78467
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5011810
• MDR Text Key: 23361469
• Report Number: 8010638-2015-00009
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K960548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 60620110
• Device Lot Number: 1502000678
• 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: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention