FDA Adverse Event
Injury
Summary report: N
XCLOSE TISSUE REPAIR SYSTEM
MDR report key: 2960847
·
Received February 11, 2013
Report
- Report Number
- 3005501497-2012-00003
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- September 16, 2010
- Report Date
- November 7, 2012
- Manufacturer
- ANULEX TECHNOLOGIES, INC
- Product Code
- GAT
- PMA / PMN Number
- K062307
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FOLLOWING SURGICAL TREATMENT OF A HERNIATED DISC IN (B)(6) 2009, THE XCLOSE TISSUE REPAIR SYSTEM WAS IMPLANTED TO RE-APPROXIMATE THE ANULUS FIBROSUS OF THE INTERVERTEBRAL DISC. THE PATIENT SUBSEQUENTLY APPROACHED A DIFFERENT SURGEON, REPORTING RECURRING BACK AND LEG SYMPTOMS. DR (B)(6) PERFORMED SPINAL FUSION TO TREAT POST-LAMINECTOMY SYNDROME WITH INSTABILITY. DURING THE SURGICAL PROCEDURE, THE SURGEON NOTED DENSE SCAR TISSUE ADHERING TO THE NERVE AT THE MARGIN OF THE DISC. A PORTION OF THE EXPULSED XCLOSE DEVICE WAS FOUND AT THE JUNCTION OF THE NERVE AND THE SCAR TISSUE. THE T-ANCHOR WITH ATTACHED SUTURE WAS REMOVED WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 60070 | XCLOSE TISSUE REPAIR SYSTEM | SUTURE, NONABSORBABLE POLYETHYLENE | GAT | ANULEX TECHNOLOGIES, INC | XC-200-01 | 102289 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other |