MAUDE Adverse Event Report: DENTSPLY DETREY GMBH SPECTRUM EXP SYR REFILL A3; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 60605283

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2023

Event Type  malfunction  

Event Description

In this event it is reported that spectrum exp syr refill a3 that was used in treatment, the material became hard and did not stick when filling a patient's tooth.Reportedly the material fell off/debonded.

Manufacturer Narrative

Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr 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: according to the responsible chemist , debonding has nothing to do with the spectrum.If the filling does not hold, it is due to the adhesive and not the composite.The adhesive used was from ivoclar and therefore cannot be tested.Complaint inconclusive.

• Brand Name: SPECTRUM EXP SYR REFILL A3
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• 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: 17334723
• MDR Text Key: 319347802
• Report Number: 8010638-2023-00024
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 60605283
• Device Lot Number: 2201000627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/10/2023
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2022
• Type of Device Usage: A
• Patient Sequence Number: 1