MAUDE Adverse Event Report: DENTSPLY LLC PALODENT UNIVERSAL MATRIX SYSTEM INTRO KIT (PV3); INSTRUMENTS, DENTAL HAND

Catalog Number	659600V
Medical Device Problem Code	Break (1069)
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, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, this event meets the criteria for reportability 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 universal matrix system intro kit (pv3) ring fractured when placed around the tooth.
Additional Manufacturer Narrative
Investigation results; return 3-2-2026: returned product 1 palodent universal blue ring (new and improved v5 design) with a broken tynes as the customer describes.Overmolding date codes verified ¿c¿ for march and ¿p¿ for 2024.Dhr and retain evaluation will be conducted.(b)(4) retain 3-2-2026: final product retains are not kept as per normal procedure.Retains from overmolding item# 759870 lot#¿s 08151425 & 08151426 were reviewed and inspected per (b)(4) and were found acceptable.(b)(4) dhr 3-2-2026: dhr for item# 659600v lot# 08122470 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any production issues while packaging/labeling the palodent v3 univ 2 ring refil.Work order 05122447 is the packaging work order which utilized 2 over-molding of the springs to rings production work orders/runs of item 759870 (v5 ring universal - palodent) in which were 08151425 (produced 03-2024) & 08151426 (produced 03-2024).Dhrs for each molding work order have also been pulled, reviewed, and attached to this case.Dhr review did not identify any issued during production with all inspections performed and deemed acceptable by the operator(s) and quality as per (b)(4).

• Brand Name: PALODENT UNIVERSAL MATRIX SYSTEM INTRO KIT (PV3)
• 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: 24092683
• Report Number: 2515379-2026-00004
• Device Sequence Number: 13347383
• Product Code: DZN
• UDI-Device Identifier: D002659600V0
• UDI-Public: D002659600V0
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 03/24/2026

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: 659600V
• Device Lot Number: 08122470
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown