MAUDE Adverse Event Report: KEYSTONE DENTAL RESTORE; 3.75X11.5 RD RBM SELFTAPPING IMP

Model Number	RS3811K
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: RESTORE
• Common Device Name: 3.75X11.5 RD RBM SELFTAPPING IMP
• Manufacturer (Section D): KEYSTONE DENTAL; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 9346623
• Report Number: 3005990499-2019-10045
• Device Sequence Number: 2606807
• Product Code: DZE
• UDI-Device Identifier: D768RS3811K0
• UDI-Public: +D768RS3811K0/$$323063040699P
• 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): 11/19/2019

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: RS3811K
• Device Catalogue Number: RS3811K
• Device Lot Number: 40699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR