MAUDE Adverse Event Report: KEYSTONE DENTAL INC RESTO; RESTORE RD 3.75X15 RBM THREADED IMP

Model Number	RS3815K
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteopenia/ Osteoporosis (2651)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: RESTO
• Common Device Name: RESTORE RD 3.75X15 RBM THREADED IMP
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 9548945
• Report Number: 3005990499-2020-20283
• Device Sequence Number: 16728127
• Product Code: DZE
• UDI-Device Identifier: D768RS3815K0
• UDI-Public: +D768RS3815K0/$$323043039531K
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/03/2020

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: RS3815K
• Device Catalogue Number: RS3815K
• Device Lot Number: 39531
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/03/2020
• 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; Required Intervention
• Patient Age: 60 YR