MAUDE Adverse Event Report: KEYSTONE DENTAL, INC. PRIMA; WD 5.0X10 PRIMACONNEX TAPER IMP TC

Model Number	15621K
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The most probable root cause is material fatigue due to high cyclic stress.
Event or Problem Description
Implant fracture.

• Brand Name: PRIMA
• Common Device Name: WD 5.0X10 PRIMACONNEX TAPER IMP TC
• Manufacturer (Section D): KEYSTONE DENTAL, INC.; 13645 alton pkwy ste a; irvine CA 92618
• Manufacturer (Section G): KEYSTONE DENTAL, INC.; 13645 alton pkwy ste a; irvine CA 92618
• Manufacturer Contact: kathleen labrie ; 13645 alton pkwy ste a; irvine, CA 92618 ; 9784308257
• MDR Report Key: 22855675
• Report Number: 3005990499-2025-71670
• Device Sequence Number: 20926174
• Product Code: DZE
• UDI-Device Identifier: D76815621K0
• UDI-Public: +D76815621K0/$$3281230WO029293R
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/20/2025

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
• Operator of Device: Health Professional
• Device Model Number: 15621K
• Device Catalogue Number: 15621K
• Device Lot Number: WO-029293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female