MAUDE Adverse Event Report: KEYSTONE DENTAL, INC. RESTO; RESTORE RD 4.0X13 RBM THREADED IMP

Model Number	RS4013K
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.
Additional Manufacturer Narrative
Keystone dental inc.Provides labeling with all implants.Failure to osseointegrate and loss of osseointegration (implant mobility) is identified as an adverse reaction and identified in the list of warnings in all endosseous dental implant labeling.The specific cause for a particular complaint is often not readily identified as there are various factors that contribute to the risk of implant failure.These include patient factors such as prior oral infection, poor bone quality or quantity, systemic conditions such as diabetes and uncontrolled hypertension.Technique factors such as overheating of the implant site may cause necrosis of the bone, preventing growth ((b)(6) 2008; (b)(6) & (b)(6) 2008).Patient habits such as tobacco use ((b)(6) & (b)(6), 2009), alcohol or drug abuse, poor oral hygiene, and bruxism ((b)(6) & (b)(6), 2009) may also lead to implant failure.In addition, improper surgical technique can lead to implant failure and/or loss of supporting bone ((b)(6) & (b)(6), 2009).

• Brand Name: RESTO
• Common Device Name: RESTORE RD 4.0X13 RBM THREADED IMP
• Manufacturer (Section D): KEYSTONE DENTAL, INC.; 154 middlesex turnpike; burlington MA 01803
• Manufacturer (Section G): KEYSTONE DENTAL, INC.; 154 middlesex turnpike; burlington MA 01803
• Manufacturer Contact: erik roman ; 154 middlesex turnpike; burlington, MA 01803 ; 7813283490
• MDR Report Key: 16843397
• Report Number: 3005990499-2023-01361
• Device Sequence Number: 17857787
• Product Code: DZE
• UDI-Device Identifier: D768RS4013K0
• UDI-Public: +D768RS4013K0/$$3231130424716
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/01/2023

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 Expiration Date: 11/29/2023
• Device Model Number: RS4013K
• Device Catalogue Number: RS4013K
• Device Lot Number: 42471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown