MAUDE Adverse Event Report: KEYSTONE DENTAL INC RESTORE; 5.0X10 WD RBM SELFTAPPING IMP

Model Number	RS5010K
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was previously submitted to the fda by keystone dental.
Event or Problem Description
Failure to osseointegrate.

• Brand Name: RESTORE
• Common Device Name: 5.0X10 WD RBM SELFTAPPING IMP
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 9659211
• Report Number: 3005990499-2020-15022
• Device Sequence Number: 16979611
• Product Code: DZE
• UDI-Device Identifier: D768RS5010K0
• UDI-Public: +D768RS5010K0/$$3231130424725
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 12/11/2019

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: RS5010K
• Device Catalogue Number: RS5010K
• Device Lot Number: 42472
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 02/03/2020
• 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: Required Intervention
• Patient Age: 69 YR