MAUDE Adverse Event Report: KEYSTONE DENTAL INC STAGE; 4.8X8 RBM STAGE1 IMP 1.8 COL

Model Number	RSR4808-2K
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.

• Brand Name: STAGE
• Common Device Name: 4.8X8 RBM STAGE1 IMP 1.8 COL
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 12250274
• Report Number: 3005990499-2021-29617
• Device Sequence Number: 14734519
• Product Code: DZE
• UDI-Device Identifier: D768RSR48082K0
• UDI-Public: +D768RSR48082K0/$$3210531293327
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/29/2021

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: RSR4808-2K
• Device Catalogue Number: RSR4808-2K
• Device Lot Number: 29332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/29/2021
• 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