FDA Adverse Event
Death
Summary report: N
6.0MM/45 DEG TI S-ROD 400MM- LEFT
MDR report key: 2880829
·
Received December 20, 2012
Report
- Report Number
- 2530088-2012-01122
- Event Type
- Death
- Date Received
- December 20, 2012
- Report Date
- November 21, 2012
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- NKB
- PMA / PMN Number
- H03009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SCREWS, LOCKING CAPS, PEDICLE HOOKS, LAMINA HOOKS, HEX-END RODS, S-RODS, CONNECTORS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH MATRIX CONSTRUCT FOR FUSION AT T2-S1 ON (B)(6) 2012. IT WAS REPORTED THE PATIENT EXPIRED ON (B)(6) 2012. THE CAUSE OF DEATH IS CURRENTLY UNKNOWN AND IS UNDER INVESTIGATION AT THE TIME OF THIS REPORT. THIS IS 17 OF 18 REPORTS FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6.0MM/45 DEG TI S-ROD 400MM- LEFT | TI S-ROD | NKB | SYNTHES BRANDYWINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Death |