MAUDE Adverse Event Report: KEYSTONE DENTAL INC PRIMA; PRIMACONNEX STRAIGHT IMP WD 5.0X10

Model Number	15435K
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was previously submitted to the fda by keystone dental.[complaint (b)(4).Pdf].
Event or Problem Description
Failure to osseointegrate.

• Brand Name: PRIMA
• Common Device Name: PRIMACONNEX STRAIGHT IMP WD 5.0X10
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 9689336
• Report Number: 3005990499-2020-15453
• Device Sequence Number: 3220892
• Product Code: DZE
• UDI-Device Identifier: D76815435K0
• UDI-Public: +D76815435K0/$$323033139283D
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/16/2020

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: 15435K
• Device Catalogue Number: 15435K
• Device Lot Number: 39283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 02/10/2020
• 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: 49 YR