MAUDE Adverse Event Report: DENTSPLY DETREY GMBH P&BOND ACTIVE ECO REF.; AGENT, TOOTH BONDING, RESIN

Catalog Number	60667342
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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.Investigation results: the device was not returned for evaluation.At the time of the complaint, the three batches mentioned had already expired several years earlier: batch: 2111000157 expiration date: october 31, 2023 batch: 2207000075 expiration date: 04/30/2024 batch: 2212000389 expiration date: 12/31/2024 for this reason, the reserve samples will not be examined.
Event or Problem Description
In this event it is reported that p&bond active eco ref.That was used in treatment did not bond.Doctor reports despite identical preparation with storage of the adhesive and use of the product the fillings are failing after a few months.There is no adhesive bond that formed between the filling material and the dentin.No injury to patient.

• Brand Name: P&BOND ACTIVE ECO REF.
• Common Device Name: AGENT, TOOTH BONDING, 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24093323
• Report Number: 8010638-2026-00008
• Device Sequence Number: 10209791
• Product Code: KLE
• UDI-Device Identifier: D010606673421
• UDI-Public: D010606673421
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 60667342
• Device Lot Number: 2212000389, 2207000075, 211100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/12/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown