FDA Adverse Event
Injury
Summary report: N
KISSIOC SUTURE SYSTEM
MDR report key: 5052703
·
Received September 1, 2015
Report
- Report Number
- 3004154314-2015-00002
- Event Type
- Injury
- Date Received
- September 1, 2015
- Report Date
- August 28, 2015
- Manufacturer
- ARTHROSURFACE, INC.
- Product Code
- HTN
- PMA / PMN Number
- K133835
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
STRESS FRACTURE OF 2ND METATARSAL FOLLOWING SURGERY WITH KISSIOC SUTURE SYSTEM. IT IS UNCERTAIN AS TO THE CAUSE OF THE FRACTURE. THE IMPLANTING SURGEON HAS PERFORMED SEVERAL SIMILAR PROCEDURES WITHOUT ISSUE. THE INCIDENT REQUIRED AN IMMOBILIZING BOOT FOR AN ADDITIONAL PERIOD OF TIME TO ALLOW THE BONE TO HEAL. NO RE-OPERATION IS PLANNED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 578834 | KISSIOC SUTURE SYSTEM | PLATE AND SUTURE SYSTEM | HTN | ARTHROSURFACE, INC. | 9V00-0100 | 75EE0721 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |