FDA Adverse Event
Injury
Summary report: N
PITUITARY RONGEUR, 2MM
MDR report key: 4925787
·
Received July 13, 2015
Report
- Report Number
- 2031966-2015-00039
- Event Type
- Injury
- Date Received
- July 13, 2015
- Date of Event
- January 29, 2015
- Report Date
- July 13, 2015
- Manufacturer
- NUVASIVE, INC.
- Product Code
- HTX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REVIEW OF THE DEVICE HISTORY RECORD NOTES NO MATERIAL NON-CONFORMANCES OR MFG ERRORS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS MODE OF FAILURE. ROOT CAUSE OF THE REPORTED EVENT IS UNDETERMINED AT THIS TIME. IT IS UNCLEAR IF THE PT'S MEDICAL HISTORY WAS A CONTRIBUTING FACTOR TO THE REPORTED BLOOD LOSS.
Description of Event or Problem · 1
DURING SURGERY ON (B)(6) 2015 AT THE T11-12 SPINE LEVEL, THE RONGEUR REPORTEDLY BROKE AND A FRAGMENT LODGED NEAR THE DURAL SPACE. RETRIEVAL REQUIRED PARTIAL CORPECTOMY. THE PT WAS REPORTED TO HAVE LOST 2.2 LITERS OF BLOOD, NECESSITATING TRANSFUSION AND EXTENDED HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 454564 | PITUITARY RONGEUR, 2MM | HTX | NUVASIVE, INC. | 6940429 | FD3573403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |