FDA Adverse Event
Injury
Summary report: N
CUSTOM SPINE, INC.
MDR report key: 1604743
·
Received February 5, 2010
Report
- Report Number
- 3005129649-2010-00001
- Event Type
- Injury
- Date Received
- February 5, 2010
- Date of Event
- January 12, 2010
- Report Date
- January 20, 2010
- Manufacturer
- CUSTOM SPINE, INC.
- Product Code
- LXH
- PMA / PMN Number
- K070281
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCTS WERE RETURNED TO CUSTOM SPINE FOR REVIEW ON 2/5/2010. THE BLOCKER INSERTER WAS ATTACHED TO BOTH RATCH-IT T-HANDLE THAT WERE RETURNED BY THE USER FACILITY. THE BLOCKER INSERTER WAS NOT ABLE OT FALL OUT OF THE T-HANDLE UNLESS THE SLEEVE WHICH LOCKS THE BLOCKER INSERTER IS LIFTED. THE BLOCKER INSERTER DIMPLES ARE FULLY FORMED AND SHOW NO SIGN OF DEFORMATION.
Description of Event or Problem · 1
PATIENT UNDERWENT SURGERY ON (B) (6) 2010 FOR COMPLETE L4 LAMINECTOMY, FACETECTOMIES, FOAMINTOMIES, DISCECTOMY/ FUSION SURGERY USING ISSYS SYSTEM. THE PHYSICIAN WAS USING THE COUNTER TORQUE WRENCH, RATCHET T-HANDLE AND BLOCKER INSERTER. THE BLOCKER INSERTER FELL INTO THE WOUND. THE FALL OF THE INSTRUMENT CAUSED A HOLE IN THE DURA WHICH WAS REPAIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CUSTOM SPINE, INC. | BLOCKER INSERTER | LXH | CUSTOM SPINE, INC. | BLOCKER INSERTER | 110909NM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | RATCHET T HANDLE (B) (4)| BLOCKER INSERTER (B) (4) |