FDA Adverse Event
Malfunction
Summary report: N
9 INCH RETRACTOR ARM ASSEMBLY
MDR report key: 4350878
·
Received December 16, 2014
Report
- Report Number
- 3004608878-2014-00238
- Event Type
- Malfunction
- Date Received
- December 16, 2014
- Report Date
- November 19, 2014
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION OH/USA
- Product Code
- GZT
- PMA / PMN Number
- K830332
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
IT IS UNK IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE TIGHTENING MECHANISM WAS DAMAGED. THE DEFECT WAS DETECTED DURING SURGERY. THERE WAS NO PATIENT INJURY OR SURGERY DELAY REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 825293 | 9 INCH RETRACTOR ARM ASSEMBLY | RETRACTOR SYSTEM COMPONENTS | GZT | INTEGRA LIFESCIENCES CORPORATION OH/USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |