FDA Adverse Event
Malfunction
Summary report: N
PATH(R) THREAD CUP ADAPTOR
MDR report key: 3825259
·
Received May 21, 2014
Report
- Report Number
- 3010536692-2014-00855
- Event Type
- Malfunction
- Date Received
- May 21, 2014
- Report Date
- April 22, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ALLEGEDLY THE CUP IMPACTOR HAS GOTTEN STUCK ON THE ATTACHMENT DEVICE THAT SCREWS INTO THE CUP. HAPPENED IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302734 | PATH(R) THREAD CUP ADAPTOR | HIP INSTRUMENT | LXH | MICROPORT ORTHOPEDICS INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |