MAUDE Adverse Event Report: KEYSTONE DENTAL INC RESTO; RESTORE RD 3.75X13 RBM THREADED IMP

Model Number	RS3813K
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Fracture.
Additional Manufacturer Narrative
On (b)(6) 2021 the implant was inspected.The implant was inspected under 20x magnification, and there was no evidence of an implant fracture.The abutment screw was fractured.It appears the clinician tried removing the remaining abutment screw piece since there was deformation on the implant internal threads where the abutment attaches to the implant, external hex, and outside body/threads of the abutment.This complaint was originally reported as a implant fracture, but after further evaluation and examination by our engineering team it has been identified that this issue was in-fact loss of osseointegration, along with an abutment screw fracture.The abutment screw fracture will be addressed under complaint # (b)(4).
Event or Problem Description
Loss of osseointegration.

• Brand Name: RESTO
• Common Device Name: RESTORE RD 3.75X13 RBM THREADED IMP
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 11852895
• Report Number: 3005990499-2021-28242
• Device Sequence Number: 19639305
• Product Code: DZE
• UDI-Device Identifier: D768RS3813K0
• UDI-Public: +D768RS3813K0/$$320123127731E
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: RS3813K
• Device Catalogue Number: RS3813K
• Device Lot Number: 27731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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