MAUDE Adverse Event Report: DENTSPLY LLC PALODENT PLUS TRIAL KIT; INSTRUMENTS, DENTAL HAND

Catalog Number	659880
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional 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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that a palodent plus trial kit - palodent ring broke during use.The ring snapped in half, one part was retrieved and other part of it went down the patient's throat.Due to the patient saying that it felt like one part was stuck in their throat ems was requested.Patient went to the ed and x-rays were taken and found that the patient had swallowed the other half.Further information requested.
Additional Manufacturer Narrative
Additional information received for investigation: product will not be returned for investigation.There is no batch information provided therefore no dhr or retain evaluation can be conducted.

• Brand Name: PALODENT PLUS TRIAL KIT
• Common Device Name: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 23449922
• Report Number: 2515379-2025-00028
• Device Sequence Number: 18382748
• Product Code: DZN
• UDI-Device Identifier: D0026598801
• UDI-Public: D0026598801
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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?: No
• Device Catalogue Number: 659880
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/31/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown