FDA Adverse Event
Injury
Summary report: N
6.0MM TI CURVED SOFT ROD 70MM
MDR report key: 1033334
·
Received April 23, 2008
Report
- Report Number
- 1719045-2008-00047
- Event Type
- Injury
- Date Received
- April 23, 2008
- Date of Event
- March 24, 2008
- Report Date
- March 24, 2008
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- KWP
- PMA / PMN Number
- K052151
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
APPROXIMATE IMPLANT DATE NOTED AS 2007. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
PT FUSED 2 LEVELS WITH PANGEA SYSTEM. PT COMPLAINED OF PAIN. REVISION SURGERY REVEALED ENTIRE PANGEA SYSTEM WAS LOOSE. SURGEON NOTED THAT HEADS OF TWO OF THE SCREWS WERE OFF. THE TWO HEADS WERE SITTING ABOVE THE SCREWS, NOT FREE FLOATING. THE SURGEON REMOVED ALL HARDWARE AND REPLACED WITH ANOTHER PANGEA SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6.0MM TI CURVED SOFT ROD 70MM | RODS (SPINE) | KWP | SYNTHES MONUMENT | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | RODS| SCREWS| LOCKING CAPS |