FDA Adverse Event
Injury
Summary report: N
MAST QUADRANT RETRACTOR SYSTEM
MDR report key: 3827710
·
Received May 22, 2014
Report
- Report Number
- 1030489-2014-02599
- Event Type
- Injury
- Date Received
- May 22, 2014
- Date of Event
- April 8, 2014
- Report Date
- April 9, 2014
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- FSZ
- PMA / PMN Number
- K043602
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
A PATIENT UNDERWENT AN OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AT L1-L4. IT WAS REPORTED THAT DURING THE OPERATION, THE DEVICE BECAME HOT AND THAT HEAT WAS SUBSEQUENTLY TRANSFERRED TO THE PATIENT¿S SKIN THROUGH A RETRACTOR FRAME. THE PATIENT WAS REPORTEDLY PRESENTED WITH LOW TEMPERATURE BURN WITH BLISTERS. THE SURGICAL TIME WAS NOT EXTENDED DUE TO THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 305815 | MAST QUADRANT RETRACTOR SYSTEM | LIGHT, SURGICAL, CARRIER | FSZ | MEDTRONIC SOFAMOR DANEK USA, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |