FDA Adverse Event
Malfunction
Summary report: N
ICON MODULAR SPINAL FIXATION SYSTEM
MDR report key: 1022797
·
Received March 28, 2008
Report
- Report Number
- 1225457-2008-00007
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- August 20, 2007
- Report Date
- March 27, 2008
- Manufacturer
- BLACKSTONE MEDICAL, INC.
- Product Code
- MNI
- PMA / PMN Number
- K042514
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS - DEVICE WAS NOT RETURNED TO MFR; NO EVAL COULD BE PERFORMED.
Description of Event or Problem · 1
SPINAL FIXATION WAS ORIGINALLY IMPLANTED IN 2007 FOR BOTH ANTERIOR AND POSTERIOR APPLICATIONS AT L4-S1. SUBSEQUENT X-RAYS TAKEN APPROX THREE MONTHS LATER REVEALED A POSTERIOR SET SCREW AND AN ANTERIOR FIXATION SCREW HAD LOOSENED. A REVISION SURGERY WAS NOT SCHEDULED, DUE TO THE PT'S EXTENUATING MEDICAL CIRCUMSTANCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICON MODULAR SPINAL FIXATION SYSTEM | SPINAL PEDICLE FIXATION | MNI | BLACKSTONE MEDICAL, INC. | 54-2001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Death| O |