FDA Adverse Event
Injury
Summary report: N
OPTIMA SPINAL FIXATION SYSTEM
MDR report key: 4380050
·
Received December 30, 2014
Report
- Report Number
- 9617297-2014-00002
- Event Type
- Injury
- Date Received
- December 30, 2014
- Date of Event
- October 22, 2014
- Report Date
- November 11, 2014
- Manufacturer
- U&I CORP.
- Product Code
- MNI
- PMA / PMN Number
- K001668
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT WAS OCCURRED AT THE HOSPITAL IN (B)(6). BUT WE REPORT THIS INCIDENT ACCORDING TO FDA REGULATION ON INCIDENT REPORT. WE ARE CURRENTLY WAITING FOR CLINICAL INFO AND THE BROKEN DEVICES.
Description of Event or Problem · 1
A PT WHO HAD AN OPERATION ON (B)(6) 2009 (DATE OF SURGERY IS UNK) AT (B)(6) HOSPITAL WENT TO RE-OPERATION ON (B)(6) 2014 DUE TO 6.0 X 200MM ROD (2 EA) AND T LINK-COLLET TYPE 40-50MM BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 858387 | OPTIMA SPINAL FIXATION SYSTEM | PEDICLE SCREW SPINAL SYSTEM | MNI | U&I CORP. | A07G040/UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |