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

Catalog Number 60620118

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/06/2015

Event Type  Injury  

Manufacturer Narrative

Therefore, because intervention was required, this event is reportable 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

It was reported that after endodontic treatment with ah plus jet on tooth # 36 a patient experienced strong pain that would not yield to painkillers, nor to anti-inflammatory drugs.Once unsealing occurred, the pain disappeared.The dentist used calcium hydroxide and performed a new sealing with a eugenate based cement.

Manufacturer Narrative

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

• Brand Name: AH PLUS JET
• 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: 5111355
• MDR Text Key: 27054428
• Report Number: 8010638-2015-00013
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Followup
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 60620118
• Device Lot Number: 1503000833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2015
• 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
• Patient Age: 44 YR