MAUDE Adverse Event Report: KEYSTONE DENTAL INC STAGE; 4.8X10 RBM WDS STAGE1 IMP 1.8 COL

Model Number	RSW4810-2K
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteopenia/ Osteoporosis (2651)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.

• Brand Name: STAGE
• Common Device Name: 4.8X10 RBM WDS STAGE1 IMP 1.8 COL
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 11457850
• Report Number: 3005990499-2021-26797
• Device Sequence Number: 11670559
• Product Code: DZE
• UDI-Device Identifier: D768RSW48102K0
• UDI-Public: +D768RSW48102K0/$$7MS007787
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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 Model Number: RSW4810-2K
• Device Catalogue Number: RSW4810-2K
• Device Lot Number: MS00778
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2021
• 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