FDA Adverse Event
Injury
Summary report: N
PERFIX SPINAL SYSTEM
MDR report key: 4537693
·
Received February 23, 2015
Report
- Report Number
- 9617297-2015-00001
- Event Type
- Injury
- Date Received
- February 23, 2015
- Report Date
- February 16, 2015
- Manufacturer
- U&I CORP.
- Product Code
- MNH
- PMA / PMN Number
- K091725
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE WERE INFORMED ABOUT THIS EVENT OCCURRED IN (B)(6) BY OUR DISTRIBUTOR. WE HAVEN'T RECEIVED ANY INFORMATION ABOUT PATIENT, AND THE DEVICES HAVEN'T NOT BEEN RETURNED YET. WE WILL FOLLOW UP ON THIS EVENT WHEN WE RECEIVE ANY INFORMATION ABOUT THE PATIENT, AND AFTER THESE BROKEN SCREWS ARE EVALUATED.
Description of Event or Problem · 1
THIS EVENT WAS OCCURRED IN (B)(6) THAT A SCREW WAS BROKEN WHILE BEING IMPLANTED IN A PATIENT. THE SCREW WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125661 | PERFIX SPINAL SYSTEM | SPINAL FIXATION SYSTEM, MNH, MNI, KWP | MNH | U&I CORP. | A11H033 OR A12A002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |