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

Catalog Number 60620112

Device Problems Failure to Align (2522); Material Integrity Problem (2978)

Patient Problem Pain (1994)

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.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 has been reported that ah plus root canal sealer did not set/cure.Patient complained of pain in tooth that was obturated.The obturation was removed and found that paste did not set.

Manufacturer Narrative

The device was evaluated and found to be within specification.A dhr review was conducted with no discrepancies noted.

• Brand Name: AH PLUS EXPORT
• Type of Device: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer (Section G): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 13480471
• MDR Text Key: 285325102
• Report Number: 8010638-2022-00010
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: RP
• 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,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 60620112
• Device Lot Number: 2104000528 (BOX), 2104000136,
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/17/2021
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention