MAUDE Adverse Event Report: KEYSTONE DENTAL PRIMA; PRIMACONNEX STRT IMP SD 3.3X11.5

Model Number	15426K
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Nerve impaction.

• Brand Name: PRIMA
• Common Device Name: PRIMACONNEX STRT IMP SD 3.3X11.5
• Manufacturer (Section D): KEYSTONE DENTAL; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 9342601
• Report Number: 3005990499-2019-10032
• Device Sequence Number: 2145458
• Product Code: DZE
• UDI-Device Identifier: D76815426K0
• UDI-Public: +D76815426K0/$$322093035960F
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/18/2019

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: 15426K
• Device Catalogue Number: 15426K
• Device Lot Number: 35960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR