FDA Adverse Event
Malfunction
Summary report: N
TITANIUM HEXALOBE SET SCREW
MDR report key: 2122265
·
Received June 13, 2011
Report
- Report Number
- 2027467-2011-00007
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- May 26, 2011
- Report Date
- May 27, 2011
- Manufacturer
- ALPHATEC SPINE INC
- Product Code
- KWP
- PMA / PMN Number
- K033090
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO EVALUATION POSSIBLE. THE DEVICE IN QUESTION HAS BEEN DISCARDED BY THE USER FACILITY. THE IDENTIFYING LOT NUMBER HAS NOT BEEN PROVIDED. CORRESPONDENCE FROM THE SALES REP CONVEYED THE EVENT CAUSED THE SURGEON NO ILL EFFECT.
Description of Event or Problem · 1
WHILE PERFORMING FINAL THE TORQUE OPERATION ON A ZODIAC SET SCREW, A SHARP EDGE/ BURR WAS SOMEHOW CREATED. THE FRAGMENT PROTRUDED FROM THE CONSTRUCT RESULTING IN THE SURGEON CUTTING HIS FINGER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TITANIUM HEXALOBE SET SCREW | KWP, MIN, MNH | KWP | ALPHATEC SPINE INC | 22015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |