FDA Adverse Event
Injury
Summary report: N
INT HEX CAP SCR 5.0MM X 45MM
MDR report key: 4242700
·
Received November 11, 2014
Report
- Report Number
- 1020279-2014-00687
- Event Type
- Injury
- Date Received
- November 11, 2014
- Date of Event
- September 2, 2014
- Report Date
- November 6, 2014
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDS
- PMA / PMN Number
- K981529
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORDS AND QUALITY RECORDS ASSOCIATED WITH THIS MANUFACTURED LOT CONFIRMED THAT NO ABNORMALITIES WERE REPORTED WITH THIS PRODUCT DURING MANUFACTURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A REVISION OF LOCKING SCREWS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725869 | INT HEX CAP SCR 5.0MM X 45MM | TITANIUM NAIL SYSTEM | JDS | SMITH & NEPHEW, INC. | 13DM06120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4) - LOT# 13DT2981 |