FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) TOTAL SHORT NECK SLEEVE
MDR report key: 4122656
·
Received September 26, 2014
Report
- Report Number
- 3010536692-2014-01429
- Event Type
- Injury
- Date Received
- September 26, 2014
- Date of Event
- March 11, 2014
- Report Date
- September 2, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE SAME EVENT AS 3010536692-2014-01428, -01430, -01431.
Description of Event or Problem · 1
ALLEGEDLY AFTER 7 MTHS POST-OP, PT. STARTED HAVING BILATERAL/CHRONIC PAIN; DIFFICULTY WITH WALKING AND MOVEMENT. RECEIVED ADDITIONAL INFORMATION ON 9/02/14: PATIENT WAS REVISED ON (B)(6) 2014 (RIGHT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 602014 | CONSERVE(R) TOTAL SHORT NECK SLEEVE | HIP COMPONENT | LZO | MICROPORT ORTHOPEDICS INC. | 1447127 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |