MAUDE Adverse Event Report: PRIMA; PRIMACONNEX STRAIGHT WD 5.0X8

Model Number	15434K
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Osteopenia/ Osteoporosis (2651)
Date of Event	09/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.

• Brand Name: PRIMA
• Common Device Name: PRIMACONNEX STRAIGHT WD 5.0X8
• MDR Report Key: 12638378
• Report Number: 3005990499-2021-30954
• Device Sequence Number: 1494900
• Product Code: DZE
• UDI-Device Identifier: D76815434K0
• UDI-Public: +D76815434K0/$$3231231430284
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

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: 12/30/2023
• Device Model Number: 15434K
• Device Catalogue Number: 15434K
• Device Lot Number: 43028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2018
• 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