FDA Adverse Event
Malfunction
Summary report: N
4WEB ANTERIOR SPINE TRUSS SYSTEM
MDR report key: 17774010
·
Received September 19, 2023
Report
- Report Number
- 3009189869-2023-00009
- Event Type
- Malfunction
- Date Received
- September 19, 2023
- Date of Event
- April 17, 2023
- Report Date
- September 19, 2023
- Manufacturer
- 4WEB, INC.
- Product Code
- MAX
- PMA / PMN Number
- K170851
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE INSERTER WAS RETURNED TO 4WEB AND ANALYZED VISUALLY. THE BROKEN THREAD WAS CONFIRMED. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE EVENT. CAUSE OF THREAD BREAKAGE IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED TO THE MANUFACTURER THAT THE INSERTER COULD NOT BE DISENGAGED FROM THE IMPLANT DURING SURGERY, LEADING TO THE TIP OF THE INSERTER BREAKING OFF IN THE IMPLANT THREADED HOLE. THE BROKEN PIECE OF THE INSERTER WAS NOT RETRIEVED AND REMAINED IN THE IMPLANT. THERE WAS NO PATIENT INJURY OR DEATH REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1586093 | 4WEB ANTERIOR SPINE TRUSS SYSTEM | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR | MAX | 4WEB, INC. | ASTS-000003 | B5899-R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male |