FDA Adverse Event
Injury
Summary report: N
INCLOSE SURGICAL MESH SYSTEM
MDR report key: 936122
·
Received October 31, 2007
Report
- Report Number
- 3005501497-2007-00015
- Event Type
- Injury
- Date Received
- October 31, 2007
- Date of Event
- August 8, 2007
- Report Date
- October 31, 2007
- Manufacturer
- ANULEX TECHNOLOGIES, INC.
- Product Code
- FTL
- PMA / PMN Number
- K050969
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THE INCLOSE MESH WAS IMPLANTED IN 2007 FOLLOWING A DISCECTOMY PROCEDURE FOR TREATMENT OF SYMPTOMS RELATED TO A HERNIATED INTERVERTEBRAL DISC AT L4-L5. ONE WEEK AFTER THE INITIAL SURGERY, IT WAS SUSPECTED THAT THE MESH HAD DISLODGED. EXPLORATORY SURGERY PERFORMED A WEEK LATER REVEALED THAT THE MESH HAD EXPULSED, MIGRATING INTO THE SPINAL CANAL. THE MESH WAS REMOVED WITHOUT INCIDENT AND THERE WERE NO CONTINUING ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INCLOSE SURGICAL MESH SYSTEM | SURGICAL MESH, POLYMERIC | FTL | ANULEX TECHNOLOGIES, INC. | INCLOSE-GSM | 100111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |