MAUDE Adverse Event Report: KEYSTONE DENTAL, INC. RESTO; RESTORE RD 3.75X10 RBM THREADED IMP

Model Number	RS3810K
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant was visually inspected using a microscope with 10-20x magnification.The coronal portion of the implant was received with the abutment still affixed with the abutment screw.The abutment and abutment screw were still intact.The implant was fractured at approximately the 3rd external thread from the collar.There were markings on the implant collar and external threads, which may have been caused by forceps during the removal from the patient.The pir indicated the implant failed more than 5 years after placement.Since no manufacturing defects were observed, the fracture was most likely caused by fatigue of the material over many chewing cycles and/or excessive chewing loads that exceeded the implant''s mechanical strength.
Event or Problem Description
Implant fracture.

• Brand Name: RESTO
• Common Device Name: RESTORE RD 3.75X10 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: ryan raymond ; 154 middlesex turnpike; burlington, MA 01803 ; 7813283676
• MDR Report Key: 16343392
• Report Number: 3005990499-2023-00816
• Device Sequence Number: 6270925
• Product Code: DZE
• UDI-Device Identifier: D768RS3810K0
• UDI-Public: +D768RS3810K0/$$3210731300188
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/09/2023

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: 07/30/2021
• Device Model Number: RS3810K
• Device Catalogue Number: RS3810K
• Device Lot Number: 30018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• 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: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2016
• 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 Age: 62 YR
• Patient Sex: Male