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

Model Number 9000-0003-B

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arthritis (1723); Arthralgia (2355)

Event Date 08/24/2022

Event Type  Injury  

Manufacturer Narrative

When reviewing records following reporting of the adverse event, restored discovered this device was associated with a previous internal complaint that the talar dome of the device was the incorrect side.Restored performed a health hazard assessment at the time with the clinician, and determined the device posed no additional risk of subsequent surgical intervention, as the mismatch would likely only occur at the far ranges of the patient's range of motion.

Event Description

In a retrospective study, restor 3d obtained information of adverse events regarding the study device.Reported event is the following: patient experienced revision ankle arthroplasty with subtalar joint arthrodesis (stj) for persistent pain and arthritis at the sub talar joint with cystic changes proximal to tibial implant.

• 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: 17890770
• MDR Text Key: 325230189
• Report Number: 3014833750-2023-00003
• 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: 04/05/2021
• Device Model Number: 9000-0003-B
• Device Catalogue Number: 9000-0003-B
• Device Lot Number: 20201223-DMP-C-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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: 36 YR
• Patient Sex: Male
• Patient Weight: 101 KG