MAUDE Adverse Event Report: 4WEB, INC.; PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT

Model Number 070517.03B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

The subject of this filing was uniquely designed for this patient's specific pathology by the prescribing physician.No product was returned to the manufacturer.No radiographs were provided.The surgeon indicated that the patient had poor bone quality.The production records were reviewed for the product involved.No manufacturing deficiences were identified that could have contributed to this event.The cause of the event could not be determined.

Event Description

A 4web custom-made device was explanted.The initial surgery was performed in (b)(6) 2017.It was reported to the manufacturer that the patient did not heal.It was also reported that the patient had a fall but no mechanical failure of 4web device was noted.The revision surgery was performed to accomplish ankle arthrodesis.Revision surgery was completed using another 4web custom-made device.

• Type of Device: PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
• Manufacturer (Section D): 4WEB, INC.; 2801 network boulevard,; suite 620; frisco TX 75034
• Manufacturer (Section G): 4WEB, INC.; 2801 network boulevard; suite 620; frisco TX 75034
• Manufacturer Contact: vareesha divakar ; 2801 network boulevard; suite 620; frisco, TX 75034 ; 8002857090
• MDR Report Key: 18783923
• MDR Text Key: 336262150
• Report Number: 3009189869-2024-00004
• Device Sequence Number: 1
• Product Code: PLF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 070517.03B
• Device Catalogue Number: 070517.03B
• Device Lot Number: 40725171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male