FDA Adverse Event
Malfunction
Summary report: N
ICON MODULAR SPINAL FIXATION SYSTEM
MDR report key: 1051479
·
Received May 21, 2008
Report
- Report Number
- 1225457-2008-00017
- Event Type
- Malfunction
- Date Received
- May 21, 2008
- Date of Event
- May 14, 2008
- Report Date
- May 21, 2008
- Manufacturer
- BLACKSTONE MEDICAL, INC.
- Product Code
- KWQ
- PMA / PMN Number
- K042514
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION METHOD AND EVALUATION RESULTS: DEVICE WAS NOT RETURNED TO MANUFACTURER; NO EVALUATION COULD BE PERFORMED.
Description of Event or Problem · 1
PT UNDERWENT AN L4-S1 TLIF MINIMALLY INVASIVE SURGERY ON (B) (6) 2008. THE SURGERY WAS PERFORMED WITHOUT INCIDENT UNTIL FINAL TIGHTENING ON THE PT'S RIGHT SIDE. IT WAS FELT THE ROD WAS TOO SHORT, THE SET SCREWS WERE LOOSENED AT L5 AND S1 IN ORDER TO MOVE THE ROD SUPERIORLY. SET SCREWS WERE RE-TIGHTENED WITH A TORQUE LIMITING DEVICE. ON (B) (6) 2008, DURING A ROUTINE FOLLOW-UP VISIT, IT WAS NOTED ON X-RAY THAT ONE OF THE SCREWS HAD PULLED OF THE ROD. A REVISION SURGERY WAS PERFORMED ON (B) (6) 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICON MODULAR SPINAL FIXATION SYSTEM | SPINAL PEDICLE FIXATION | KWQ | BLACKSTONE MEDICAL, INC. | 54-2001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Other |