FDA Adverse Event
Injury
Summary report: N
EXPEDIUM PRE-CUT HEX END ROD, 5.5X300MM, TI
MDR report key: 2073602
·
Received April 27, 2011
Report
- Report Number
- 1526439-2011-00071
- Event Type
- Injury
- Date Received
- April 27, 2011
- Date of Event
- February 28, 2011
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- NKB
- PMA / PMN Number
- K033901
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ROD HAS BEEN RETURNED FOR EVAL. A F/U REPORT WILL BE FILED UPON COMPLETION OF THE EVAL.
Description of Event or Problem · 1
CONTACT REPORTS THAT REVISION SURGERY WAS PERFORMED DUE TO THE BREAKAGE OF TWO RODS. IT WAS REPORTED THAT THE DELAY IN NOTIFYING DEPUY SPINE OF THE EVENT WAS BECAUSE THE IMPLANT WAS MISPLACED AT THE HOSP. SALES REP HAS BEEN ADVISED OF REPORTING REQUIREMENTS. SEE MFG MEDWATCH REPORT# 1526439-2011-00072 FOR THE SECOND ROD THAT WAS INVOLVED IN THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXPEDIUM PRE-CUT HEX END ROD, 5.5X300MM, TI | SPINAL FIXATION DEVICE | NKB | DEPUY SPINE, INC. | NA | UI089130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |