FDA Adverse Event
Injury
Summary report: N
AXLE INTERSPINOUS FUSION SYSTEM TORQUE HANDLE
MDR report key: 2161803
·
Received July 8, 2011
Report
- Report Number
- 3005031160-2011-00007
- Event Type
- Injury
- Date Received
- July 8, 2011
- Report Date
- June 10, 2011
- Manufacturer
- X-SPINE SYSTEMS, INC.
- Product Code
- KWP
- PMA / PMN Number
- K101471
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL OF THE PRODUCT IS CURRENTLY BEING PERFORMED, BUT A ROOT CAUSE HAS NOT YET BEEN DETERMINED.
Description of Event or Problem · 1
PROCEDURE TYPE: TWO-LEVEL INTERSPINOUS FUSION. ACCORDING TO THE REPORTER: IT WAS DIFFICULT TO ACTUATE THE HANDLE AND THE TIP OF THE SCREW DRIVER BROKE OFF IN THE LOCKING PLATE DURING FINAL TIGHTENING. THE SURGEON WAS UNABLE TO REMOVE THE TIP OF THE DRIVER FROM THE IMPLANT SET SCREW. THE SURGEON THEN DECIDED TO REMOVE ONE OF THE INTERSPINOUS PROCESSES TO COMPLETE THE SURGERY. THE LOWER LEVEL IMPLANT WAS NOT REMOVED. NO ADDITIONAL INFO WAS RECEIVED REGARDING THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXLE INTERSPINOUS FUSION SYSTEM TORQUE HANDLE | INTERSPINOUS FUSION SYSTEM TORQUE HANDL | KWP | X-SPINE SYSTEMS, INC. | X060-0323 | 525941 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | LOT: 106375| AXLE SCREWDRIVER: PART NUMBER X060-0320 |