FDA Adverse Event
Malfunction
Summary report: N
4WEB CERVICAL SPINE TRUSS SYSTEM - STAND ALONE
MDR report key: 20446326
·
Received October 14, 2024
Report
- Report Number
- 3009189869-2024-00018
- Event Type
- Malfunction
- Date Received
- October 14, 2024
- Report Date
- October 14, 2024
- Manufacturer
- 4WEB, INC.
- Product Code
- OVE
- UDI-DI
- 00812998039326
- PMA / PMN Number
- K190870
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED AS THE SCREW REMAINS IMPLANTED IN PATIENT. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUE RELATED TO MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE CAUSE OF THE EVENT COULD NOT BE ESTABLISHED WITH THE INFORMATION AVAILABLE TO THE MANUFACTURER. NO REVISION SURGERY WAS SCHEDULED AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 0
IT WAS REPORTED TO 4WEB MEDICAL THAT A 16MM CERVICAL SCREW APPEARS TO HAVE BROKEN IN PATIENT. THE ISSUE WAS DISCOVERED DURING 3MONTH POST-OP FOLLOW-UP. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1810727 | 4WEB CERVICAL SPINE TRUSS SYSTEM - STAND ALONE | INTERBODY FUSION DEVICE | OVE | 4WEB, INC. | CSCR-3516-SP | R001 | 00812998039326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |