FDA Adverse Event
Injury
Summary report: N
SONIC CTRL SERRATED AGG KNIFE
MDR report key: 3283707
·
Received August 13, 2013
Report
- Report Number
- 0001811755-2013-01921
- Event Type
- Injury
- Date Received
- August 13, 2013
- Date of Event
- July 23, 2013
- Report Date
- July 23, 2013
- Manufacturer
- STRYKER INSTRUMENTS-INAGI
- Product Code
- LFL
- PMA / PMN Number
- K010309
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SONIC CTRL SERRATED AGG KNIFE WAS BEING USED IN A POSTERIOR CERVICAL FUSION PROCEDURE WHEN THE RESIDENT PLACED THE DEVICE TOO LOW IN THE LAMINA AND PUNCTURED THE DURA, REQUIRING STITCHES. THERE WERE NO PERMANENT INJURIES OR HARM AS A RESULT OF THIS EVENT FOR THE PATIENT. IT WAS CONFIRMED THAT THE DEVICE DID NOT MALFUNCTION IN ANY WAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 388569 | SONIC CTRL SERRATED AGG KNIFE | INSTRUMENT, ULTRASONIC SURGICAL | LFL | STRYKER INSTRUMENTS-INAGI | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | UNIVERSAL HANDPIECE 5450-820-000| CONSOLE 110V (PEDAL&POLE INCLD) 5450-850-000| SONOPET TUBING KIT ASM 5450-850-310 |