FDA Adverse Event
Injury
Summary report: N
TRINITY
MDR report key: 4543378
·
Received April 29, 2014
Report
- Report Number
- 9614209-2014-00035
- Event Type
- Injury
- Date Received
- April 29, 2014
- Date of Event
- April 1, 2014
- Report Date
- April 28, 2014
- Manufacturer
- CORIN MEDICAL, LTD.
- Product Code
- LZO
- PMA / PMN Number
- K111481
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) INITIAL REPORT. DEVICE DETAILS, PT MED HISTORY, POST PRIMARY AND PRE REVISION X RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MFG RECORDS TO BE REVIEWED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA; HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.
Description of Event or Problem · 1
TRINITY REVISION AFTER 10 MONTHS DUE TO LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258113 | TRINITY | LZO | CORIN MEDICAL, LTD. | 321.04.354 | 251764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | TRINITY LINER ECIMA 322.04.636 LOT 255604 |