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

Catalog Number	60667343
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.No returned product, no lot applicable no investigation possible.
Event or Problem Description
In this event it is reported that a doctor alleged that the use of p&bond active sud ref.The product does not adhere and the fillings of the patient's fall out after a few months.The doctor no longer has the product, they were unable to give a complete count of how many patients were affected.

• Brand Name: P&BOND ACTIVE SUD 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: 24018964
• Report Number: 8010638-2026-00001
• Device Sequence Number: 8970217
• Product Code: KLE
• UDI-Device Identifier: D010606673431
• UDI-Public: D010606673431
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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): 01/09/2026

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: 60667343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/07/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown