FDA Adverse Event
Malfunction
Summary report: N
CONFIDENCE INTRODUCER NEEDLE, DIAMOND, 13G 4"
MDR report key: 1396821
·
Received March 12, 2009
Report
- Report Number
- 1526439-2009-00045
- Event Type
- Malfunction
- Date Received
- March 12, 2009
- Date of Event
- February 17, 2009
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- GAA
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE MADE. THE BROKEN NEEDLE IS NOT AVAILABLE FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT MET SPEC REQUIREMENTS WHEN RELEASED TO STOCK. NO OTHER PRODUCT COMPLAINTS HAVE BEEN REPORTED FOR THIS ITEM. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.
Description of Event or Problem · 1
INTERNATIONAL AFFILIATE REPORTS THE TIP OF THE INTRODUCER NEEDLE BROKE OFF WHEN INSERTED DURING A VERTEBRAL BODY AUGMENTATION PROCEDURE. THE BROKEN TIP REMAINS IN THE PT'S PEDICLE. THE REMAINING SECTION OF THE NEEDLE WAS DISCARDED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONFIDENCE INTRODUCER NEEDLE, DIAMOND, 13G 4" | INTRODUCER NEEDLE | GAA | DEPUY SPINE, INC. | NA | CJPCBZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |