FDA Adverse Event
Malfunction
Summary report: N
3.5MM LCK TUBULAR PL 6H 82MM
MDR report key: 8017295
·
Received October 29, 2018
Report
- Report Number
- 1020279-2018-02292
- Event Type
- Malfunction
- Date Received
- October 29, 2018
- Date of Event
- October 2, 2018
- Report Date
- November 27, 2018
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HRS
- UDI-DI
- 03596010523211
- PMA / PMN Number
- K033669
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION STATES THAT THIS EVENT HAD ALREADY BEEN REPORTED UNDER REPORT NO. 1020279-2018-02296.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER SURGERY THE ULNA PLATE BROKE. NO DELAY, INJURY OR BACK UP REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 856983 | 3.5MM LCK TUBULAR PL 6H 82MM | PLATE, FIXATION, BONE | HRS | SMITH & NEPHEW, INC. | 17LT94828 | 03596010523211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |