FDA Adverse Event
Injury
Summary report: N
XCLOSE TISSUE REPAIR SYSTEM
MDR report key: 1373458
·
Received April 30, 2009
Report
- Report Number
- 3005501497-2009-00004
- Event Type
- Injury
- Date Received
- April 30, 2009
- Date of Event
- March 20, 2009
- Report Date
- April 30, 2009
- Manufacturer
- ANULEX TECHNOLOGIES, INC
- Product Code
- GAT
- PMA / PMN Number
- K062307
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THE XCLOSE TISSUE REPAIR SYSTEM WAS IMPLANTED IN 2009, FOLLOWING A DISCECTOMY PROCEDURE FOR TREATMENT OF SYMPTOMS RELATED TO A HERNIATED INTERVERTEBRAL DISC. THE PATIENT RETURNED TO THE CLINIC 3 WEEKS LATER WITH PAIN. EXPLORATORY SURGERY WAS PERFORMED THE FOLLOWING MONTH, AND REVEALED EXPULSION OF THE DEVICE. A GRANULOMA THAT HAD FORMED AROUND THE DEVICE WAS REMOVED. LABORATORY ANALYSIS OF THE GRANULOMA IDENTIFIED FUNGUS AS WELL AS S. AUREUS. INVESTIGATION OF DEVICE HISTORY RECORDS REVEALED NO INCONSISTENCIES IN DEVICE PACKAGING OR STERILIZATION AND COMPLAINT RECORDS INDICATE NO OTHER REPORTS OF INFECTION OR ADVERSE REACTION TO THE PRODUCT FROM THE LOT OF DEVICES IN QUESTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XCLOSE TISSUE REPAIR SYSTEM | SURGICAL SUTURE | GAT | ANULEX TECHNOLOGIES, INC | XCLOSE-TRS | 100926 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention |