FDA Adverse Event
Injury
Summary report: N
ADVANCE(R) EVOLUTION(R) PIN PACK***
MDR report key: 4235842
·
Received November 7, 2014
Report
- Report Number
- 3010536692-2014-01570
- Event Type
- Injury
- Date Received
- November 7, 2014
- Date of Event
- February 3, 2014
- Report Date
- October 8, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LHX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/ LOT.
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 3010536692-2014-01356_01, -01566, -01567, -01568, -01569, -01571.
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT WAS REVISED DUE TO A SIZING ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 716498 | ADVANCE(R) EVOLUTION(R) PIN PACK*** | KNEE INSTRUMENT | LHX | MICROPORT ORTHOPEDICS INC. | 1464747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |