FDA Adverse Event Injury Summary report: N

PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT

MDR report key: 23783716 · Received December 11, 2025

Report

Report Number: 3009189869-2025-00011
Event Type: Injury
Date Received: December 11, 2025
Report Date: December 11, 2025
Manufacturer: 4WEB, INC.
Product Code: PLF
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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 AS THE DEVICE REMAINS IMPLANTED. 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. A FOLLOW-UP REPORT WILL BE SUBMITTED AS MORE INFORMATION IS MADE AVAILABLE. THE ORIGINAL REPORT WAS SUBMITTED TO THE FDA ON 05-SEP-2025; HOWEVER, FDA REQUESTED 4WEB TO RESUBMIT AS THE INITIAL APPLICATION WAS ROUTED TO RADIOLOGICAL HEALTH INSTEAD OF HL7. THIS FILING IS A RE-SUBMISSION OF THE SAME REPORT. NO CHANGES HAVE BEEN MADE TO THE CONTENT PREVIOUSLY SUBMITTED.

Description of Event or Problem · 0

IT WAS REPORTED TO THE MANUFACTURER THAT THE EXISTING 4WEB CUSTOM-MADE DEVICE NEEDS TO BE REPLACED AS THE PATIENT HAD ANOTHER FRACTURE LEADING TO DETERIORATION OF THE DISTAL TIBIA. INITIAL SURGERY, PERFORMED ON (B)(6) 2023, WAS TO ADDRESS AN EXISTING TIBIAL SHAFT FRACTURE. THE 4WEB CUSTOM MADE DEVICE WILL BE REPLACED BY ANOTHER 4WEB CUSTOM MADE DEVICE. THE DATE OF REVISION SURGERY HAS NOT BEEN FINALIZED YET.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2139003		PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT	PLF	4WEB, INC.	101223.12B	103338

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Male	Other