MAUDE Adverse Event Report: DENTSPLY DETREY GMBH SUREFIL ONE INTRO KIT; CEMENT, DENTAL

Catalog Number 60300200

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

In this event it is reported that surefil one intro kit that was used reportedly fell out - debonded.Doctor stated they had some surefil one material that they initially used and had some debonding.He stated that the material is now expired and been thrown out but he had a lot number saved for us.No injuries to patients.

Manufacturer Narrative

While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Manufacturer Narrative

Investigation found: the device/material expired.Root cause: out of lifetime.Conclusion code: service life or shelf life exceeded.

• Brand Name: SUREFIL ONE INTRO KIT
• Type of Device: CEMENT, DENTAL
• 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: 16283030
• MDR Text Key: 308651706
• Report Number: 8010638-2023-00018
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 60300200
• Device Lot Number: 2101000496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/30/2023
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1