MAUDE Adverse Event Report: KEYSTONE DENTAL INC PRIMA; PRIMACONNEX TC STRAIGHT WD 5.0X11.5

Model Number	15636K
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Osteopenia/ Osteoporosis (2651)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: PRIMA
• Common Device Name: PRIMACONNEX TC STRAIGHT WD 5.0X11.5
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 11033484
• Report Number: 3005990499-2020-25571
• Device Sequence Number: 14126304
• Product Code: DZE
• UDI-Device Identifier: D76815636K0
• UDI-Public: +D76815636K0/$$324123147854K
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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: 15636K
• Device Catalogue Number: 15636K
• Device Lot Number: 47854
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Congenital Anomaly; Other; Required Intervention
• Patient Age: 61 YR