FDA Adverse Event
Malfunction
Summary report: N
TIGER CANNULATED SCREW
MDR report key: 6598045
·
Received May 30, 2017
Report
- Report Number
- 3007420745-2017-00010
- Event Type
- Malfunction
- Date Received
- May 30, 2017
- Date of Event
- May 5, 2017
- Report Date
- May 16, 2017
- Manufacturer
- TRILLIANT SURGICAL, LTD
- Product Code
- HWC
- UDI-DI
- 00812926021027
- PMA / PMN Number
- K153338
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
A PATIENT CAME BACK INTO THE DOCTORS OFFICE TO REPORT PAIN IN HER FOOT. THE DOCTOR X-RAYED HER FOOT AND NOTICED THAT THE SCREWS WERE DISLOCATED FROM THE FUSION SITE. THE DOCTOR SUSPECTS NON-COMPLIANCE AND DECIDED TO REMOVE THE TWO TIGER CANNULATED SCREWS ON (B)(6) 2017. THE TWO SCREWS WERE REMOVED WITHOUT ANY DIFFICULTY. THE DOCTOR DID NOT PUT ANY OTHER HARDWARE BACK IN THE PATIENT ON (B)(6) 2017 AS THE PATIENT HAD EDEMA AND HE DID NOT WANT TO FURTHER IRRITATE THE SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380723 | TIGER CANNULATED SCREW | BONE SCREW | HWC | TRILLIANT SURGICAL, LTD | 00812926021027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |