MAUDE Adverse Event Report: RESTO; 6.0X15 WD RBM SELFTAPPING IMP

Model Number	RS6015K
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteopenia/ Osteoporosis (2651)
Date of Event	09/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: RESTO
• Common Device Name: 6.0X15 WD RBM SELFTAPPING IMP
• MDR Report Key: 12733706
• Report Number: 3005990499-2021-31181
• Device Sequence Number: 16520713
• Product Code: DZE
• UDI-Device Identifier: D768RS6015K0
• UDI-Public: +D768RS6015K0/$$321073111210S2V
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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 Expiration Date: 08/31/2021
• Device Model Number: RS6015K
• Device Catalogue Number: RS6015K
• Device Lot Number: 11210-S2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention