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

Model Number	RS4011K
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Osteopenia/ Osteoporosis (2651)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.

• 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: 9659285
• Report Number: 3005990499-2020-15034
• Device Sequence Number: 11631548
• Product Code: DZE
• UDI-Device Identifier: D768RS4011K0
• UDI-Public: +D768RS4011K0/$$3230930416307
• 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): 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: RS4011K
• Device Catalogue Number: RS4011K
• Device Lot Number: 41630
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2019
• 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