FDA Adverse Event
Injury
Summary report: N
MAST QUADRANT RETRACTOR SYSTEM
MDR report key: 3738344
·
Received April 10, 2014
Report
- Report Number
- 1030489-2014-02142
- Event Type
- Injury
- Date Received
- April 10, 2014
- Date of Event
- March 11, 2014
- Report Date
- March 11, 2014
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- FSZ
- PMA / PMN Number
- K043602
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). LOCATION: HOSPITAL . THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE FOR DLIF AT L2-3. THE SURGEON USED A LIGHT SOURCE AND WHEN IT WAS REMOVED FROM THE TUBE THE SURGEON PLACED THE LIGHT SOURCE ON THE DRAPE WHICH SUBSEQUENTLY BURNED THE PATIENT ON THE SHOULDER AREA. THE BURN WAS TREATED AND THERE WERE NO FURTHER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 217824 | MAST QUADRANT RETRACTOR SYSTEM | LIGHT, SURGICAL, CARRIER | FSZ | WARSAW ORTHOPEDICS | NA | 0292423W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Required Intervention |