FDA Adverse Event
Injury
Summary report: N
VOLT INSERTER GATOR SQUID INTECH GREEN
MDR report key: 2711406
·
Received August 16, 2012
Report
- Report Number
- 3005739886-2012-00004
- Event Type
- Injury
- Date Received
- August 16, 2012
- Date of Event
- June 25, 2012
- Report Date
- August 3, 2012
- Manufacturer
- SPINAL USA, INC
- Product Code
- KWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
OTHER - EVAL IN PROGRESS, UPON COMPLETION A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON (B)(6) 2012, THE VOLT INSERTER GATOR INSTRUMENT BOUND UP PRODUCING METAL SHAVINGS THAT HAD TO BE REMOVED FROM THE PT'S WOUND. RADIOGRAPHS WERE PERFORMED TO CONFIRM THAT ALL DEBRIS WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH FURTHER ISSUE AND NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VOLT INSERTER GATOR SQUID INTECH GREEN | VOLT INSERTER GATOR SQUID INTECH GREEN | KWQ | SPINAL USA, INC | 1526501A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |