FDA Adverse Event
Malfunction
Summary report: N
CONFIDENCE INTRODUCER NEEDLE, SIDE HOLE, 13G 4"
MDR report key: 2152304
·
Received June 23, 2011
Report
- Report Number
- 1526439-2011-00109
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- June 3, 2011
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- DYB
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF TIP BREAKAGE. HOWEVER, THE BENDED SHAFT ON THE RETURNED PORTION OF THE INTRODUCER NEEDLE IS INDICATIVE OF THE APPLICATION OF SIDE FORCES UPON THE DEVICE DURING USAGE. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.
Description of Event or Problem · 1
CONTACT REPORTS THAT AS THE DOCTOR WAS INSERTING THE NEEDLE INTO THE PEDICLE DURING VERTEBROPLASTY, THE TIP BROKE AND IT REMAINED IN THE PT'S PEDICLE AT L3 LEVEL. AS AN UNINTENDED PORTION OF THE DEVICE REMAINS IN THE PT, THIS MEDWATCH REPORT IS BEING FILED TO DOCUMENT THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONFIDENCE INTRODUCER NEEDLE, SIDE HOLE, 13G 4" | INTRODUCER NEEDLE | DYB | DEPUY SPINE, INC. | NA | HMFBDB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |