FDA Adverse Event
Injury
Summary report: N
PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
MDR report key: 20065689
·
Received August 26, 2024
Report
- Report Number
- 3009189869-2024-00013
- Event Type
- Injury
- Date Received
- August 26, 2024
- Report Date
- August 26, 2024
- Manufacturer
- 4WEB, INC.
- Product Code
- PLF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THE CASE FILE RECORDS WERE REVIEWED, NO MANUFACTURING DEVIATIONS WERE NOTED. BASED ON THE INFORMATION AVAILABLE AT THE POINT, IT IS UNCLEAR IF THE EVENT IS LINKED TO 4WEB DEVICE. IF MORE INFORMATION IS MADE AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. IT WAS REPORTED THAT CALCANEAL SUSTENTACULUM TALI FRACTURED DURING THE INITIAL SURGERY WHICH TOOK PLACE ON (B)(6) 2021. ABOUT TWO AND HALF YEARS POST INITIAL SURGERY, IT WAS REPORTED TO THE MANUFACTURER THAT PATIENT'S RIGHT LEG, BELOW-THE-KNEE, WAS AMPUTATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270680 | PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT | PLF | 4WEB, INC. | 111620.07B | JI103747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Disability |