MAUDE Adverse Event Report: KEYSTONE DENTAL INC STAGE; 4.8X12 RBM WDS STAGE1 IMP 1.8 COL

Model Number	RSW4812-2K
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: STAGE
• Common Device Name: 4.8X12 RBM WDS STAGE1 IMP 1.8 COL
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 9531287
• Report Number: 3005990499-2019-20097
• Device Sequence Number: 11425816
• Product Code: DZE
• UDI-Device Identifier: D768RSW48122K0
• UDI-Public: +D768RSW48122K0/$$3240131431667
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/24/2019

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: RSW4812-2K
• Device Catalogue Number: RSW4812-2K
• Device Lot Number: 43166
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 12/30/2019
• 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: Congenital Anomaly; Required Intervention