FDA Adverse Event
Injury
Summary report: N
INCLOSE SURGICAL MESH SYSTEM
MDR report key: 1365115
·
Received April 17, 2009
Report
- Report Number
- 3005501497-2009-00003
- Event Type
- Injury
- Date Received
- April 17, 2009
- Date of Event
- January 29, 2008
- Report Date
- April 17, 2009
- Manufacturer
- ANULEX TECHNOLOGIES, INC.
- Product Code
- FTL
- PMA / PMN Number
- K050969
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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 L5-S1. THE PT RETURNED TO THE CLINIC ONE MONTH LATER WITH RECURRENT LEFT S1 RADICULOPATHY. EXPLORATORY SURGERY WAS PERFORMED IN 2008. AFTER REMOVAL OF RECURRENT DISC EXTRUSION, THE MESH WAS FOUND TO BE CONTAINED WITHIN THE DISC SPACE. THE MESH WAS REMOVED AND AGGRESSIVE DISCECTOMY WAS PERFORMED UNTIL THE DISC SPACE WAS LARGELY EMPTIED. THE PT WAS DISCHARGED THE FOLLOWING DAY WITHOUT COMPLICATIONS. THE PT WAS LAST SEEN FOR F/U THREE MONTHS LATER, AND REPORTED SOME RESIDUAL NUMBNESS. A NON-SURGICAL COURSE OF TREATMENT WAS RECOMMENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INCLOSE SURGICAL MESH SYSTEM | SURGICAL MESH, POLYMERIC | FTL | ANULEX TECHNOLOGIES, INC. | INCLOSE-XR | 100347 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |