MAUDE Adverse Event Report: RESTOR3D RESTOR3D; PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT

Model Number 9000-0003-A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arthritis (1723); Muscle/Tendon Damage (4532)

Event Date 08/25/2022

Event Type  Injury  

Event Description

In a retrospective study, restored obtained information of adverse events regarding the study device.The event was not reported as a complaint by the customer, and there was no device defect or malfunction related to the device at the time of surgery.Reported event is the following: patient experienced prosthetic loosening and pain leading to postop arthritis and tibial cystic formation; had a revision total ankle replacement (tar), tendon repair, and removal of the implant.

Manufacturer Narrative

Review of device design and production records revealed no errors in design nor production that would have caused the adverse event.

• Brand Name: RESTOR3D
• Type of Device: PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
• Manufacturer (Section D): RESTOR3D; 4001 nc hwy 54; suite 2160; durham NC 27709
• Manufacturer (Section G): RESTOR3D; 4001 nc hwy 54; suite 2160; durham NC 27709
• Manufacturer Contact: tiffany wu ; 4001 nc hwy 54; suite 2160; durham, NC 27709 ; 9848880593
• MDR Report Key: 17890775
• MDR Text Key: 325229842
• Report Number: 3014833750-2023-00004
• Device Sequence Number: 1
• Product Code: QNN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 520(B) EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2021
• Device Model Number: 9000-0003-A
• Device Catalogue Number: 9000-0003-A
• Device Lot Number: 20210127-DMP-C-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female