MAUDE Adverse Event Report: KEYSTONE DENTAL, INC. PRMA+; PRIMA PLUS IMPLANT 5.0X15.0 MM

Model Number	15744K
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Failed to osseointegrate.

• Brand Name: PRMA+
• Common Device Name: PRIMA PLUS IMPLANT 5.0X15.0 MM
• Manufacturer (Section D): KEYSTONE DENTAL, INC.; 154 middlesex turnpike; burlington MA 01803
• Manufacturer (Section G): KEYSTONE DENTAL, INC.; 154 middlesex turnpike; burlington MA 01803
• Manufacturer Contact: erik roman ; 154 middlesex turnpike; burlington, MA 01803 ; 7813283490
• MDR Report Key: 21609850
• Report Number: 3005990499-2025-70420
• Device Sequence Number: 15757384
• Product Code: DZE
• UDI-Device Identifier: D76815744K0
• UDI-Public: +D76815744K0/$$3271115WO023973X
• 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): 03/14/2025

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: 15744K
• Device Catalogue Number: 15744K
• Device Lot Number: WO-023973
• 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: 03/07/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2022
• 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: 58 YR
• Patient Sex: Male