MAUDE Adverse Event Report: KEYSTONE DENTAL INC RESTORE; 4.0X11.5 RD RBM SELFTAPPING IMP

Model Number	RS4011K
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was previously submitted to the fda by keystone dental.Complaint (b)(4).
Event or Problem Description
Failure to osseointegrate.

• Brand Name: RESTORE
• Common Device Name: 4.0X11.5 RD RBM SELFTAPPING IMP
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 9661933
• Report Number: 3005990499-2020-15265
• Device Sequence Number: 19681264
• Product Code: DZE
• UDI-Device Identifier: D768RS4011K0
• UDI-Public: +D768RS4011K0/$$3210331282086
• 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): 01/09/2020

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: RS4011K
• Device Catalogue Number: RS4011K
• Device Lot Number: 28208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2019
• 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: Other; Required Intervention
• Patient Age: 60 YR