MAUDE Adverse Event Report: KEYSTONE DENTAL INC PRIMA; PRIMACONNEX TC TAPERED SD 3.5X15

Model Number	15616K
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Osteopenia/ Osteoporosis (2651)
Date of Event	11/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: PRIMA
• Common Device Name: PRIMACONNEX TC TAPERED SD 3.5X15
• 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: ryan raymond ; 154 middlesex turnpike; burlington, MA 01803 ; 7813283676
• MDR Report Key: 13029789
• Report Number: 3005990499-2021-31946
• Device Sequence Number: 11875263
• Product Code: DZE
• UDI-Device Identifier: D76815616K0
• UDI-Public: +D76815616K0/$$3250716WO014327S
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/17/2021

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 Expiration Date: 07/15/2025
• Device Model Number: 15616K
• Device Catalogue Number: 15616K
• Device Lot Number: WO-014327
• 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: 11/30/2021
• Initial Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2020
• 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: Other; Required Intervention
• Patient Sex: Unknown