FDA Adverse Event
Injury
Summary report: N
AXLE INTERSPINOUS FUSION SYSTEM SCREW DRIVER
MDR report key: 2496437
·
Received March 8, 2012
Report
- Report Number
- 3005031160-2012-00004
- Event Type
- Injury
- Date Received
- March 8, 2012
- Date of Event
- February 14, 2012
- Report Date
- February 14, 2012
- Manufacturer
- X-SPINE SYSTEMS, INC.
- Product Code
- KWP
- PMA / PMN Number
- K101471
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: THREE-LEVEL ILIF, LEVELS L2-3, L3-4, AND L4-5. DATE OF INITIAL SURGERY: (B)(6) 2012. ACCORDING TO THE REPORTER: BOTH DRIVERS BROKE ON THE AXLE DURING THE CASE. THE FIRST DRIVER BROKE WHEN LOCKING DOWN THE SET SCREW ON THE SECOND LEVEL. THE HANDLE CLICKED OVER ONCE AND THEN BROKE WHEN TRYING TO CLICK OVER A SECOND TIME. THE SECOND DRIVER BROKE WHEN LOCKING DOWN THE SET SCREW ON THE THIRD LEVEL. THE HANDLE CLICKED OVER AT LEAST ONCE AND THEN BROKE WHEN TRYING TO CLICK OVER AGAIN. THE DISTAL TIP OF THE DRIVERS WERE LEFT INSIDE OF THE SET SCREW AFTER EACH TIP BROKE OFF. THE SURGEON NEVER INDICATED IT WAS DIFFICULT TO ACTUATE THE HANDLE. THE OPERATION WAS ABLE TO BE COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXLE INTERSPINOUS FUSION SYSTEM SCREW DRIVER | INTERSPINOUS FUSION SCREW DRIVER | KWP | X-SPINE SYSTEMS, INC. | X060-0320 | 60135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | SERIAL # (B)(4)| TORQUE HANDLE, X060-0323: LOT 525942R |