MAUDE Adverse Event Report: KEYSTONE DENTAL, INC. PRIMA; PRIMACONNEX TC STRAIGHT RD 4.0X8

Model Number	15629K
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Bruxism (4427); Implant Pain (4561)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional health effect clinical code=(b)(4), cancer/cancer treatment.
Event or Problem Description
Loss of osseointegration.

• Brand Name: PRIMA
• Common Device Name: PRIMACONNEX TC STRAIGHT RD 4.0X8
• 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: 19148768
• Report Number: 3005990499-2024-70726
• Device Sequence Number: 15279749
• Product Code: DZE
• UDI-Device Identifier: D76815629K0
• UDI-Public: +D76815629K0/$$3271025WO023532Q
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 04/19/2024

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: 15629K
• Device Catalogue Number: 15629K
• Device Lot Number: WO-023532
• 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: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2022
• 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: 63 YR
• Patient Sex: Female