FDA Adverse Event
Injury
Summary report: N
4WEB CERVICAL SPINE TRUSS SYSTEM - STAND ALONE
MDR report key: 12990401
·
Received December 13, 2021
Report
- Report Number
- 3009189869-2021-00007
- Event Type
- Injury
- Date Received
- December 13, 2021
- Date of Event
- November 15, 2021
- Report Date
- December 13, 2021
- Manufacturer
- 4WEB, INC.
- Product Code
- OVE
- PMA / PMN Number
- K190870
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE IS NO INFORMATION AVAILABLE ON THE INITIAL SURGERY WHERE THE 4WEB CERVICAL CAGE WAS IMPLANTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS FURTHER INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
IT WAS REPORTED TO THE MANUFACTURER THAT A REVISION SURGERY WAS PERFORMED ON A 4WEB IMPLANT ON (B)(6) 2021. THE DEVICE INVOLVED IN THE ADVERSE EVENT IS A STAND-ALONE 4WEB CERVICAL CAGE. NO OTHER INFORMATION WAS PROVIDED TO THE MANUFACTURER. THE CERVICAL CAGE USED IN THE SURGERY IS BEING REPORTED IN THIS SUBMISSION. DEVICE 1 OF 2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1885443 | 4WEB CERVICAL SPINE TRUSS SYSTEM - STAND ALONE | INTERBODY FUSION DEVICE | OVE | 4WEB, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Male | Required Intervention |