FDA Adverse Event
Injury
Summary report: N
EXPEDIUM SINGLE INNIE SET SCREW
MDR report key: 2113726
·
Received June 2, 2011
Report
- Report Number
- 1526439-2011-00090
- Event Type
- Injury
- Date Received
- June 2, 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
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO DEFINITIVE CONCLUSIONS CAN BE MADE. CARE MUST BE TAKEN TO ENSURE THAT THE CONSTRUCT IS TIGHTENED PROPERLY. CONSTRUCT LOOSENING IS LISTED AS A POSSIBLE ADVERSE OUTCOME IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.
Description of Event or Problem · 1
INTERNATIONAL AFFILIATE REPORTS TWO SINGLE INNIE SET SCREWS BECAME LOOSE WITHIN THE SPINAL CONSTRUCT AND A ROD SLIPPED OUT OF THE PEDICLE SCREW HEADS. REVISION SURGERY WAS PERFORMED. MFG MEDWATCH REPORT# 1526439-2011-00089 IS BEING FILED FOR THE OTHER SINGLE INNIE SET SCREW INVOLVED IN THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXPEDIUM SINGLE INNIE SET SCREW | SPINAL FIXATION DEVICE | NKB | DEPUY SPINE, INC. | NA | AMBBY1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | EXPEDIUM ROD: PRODUCT CODE UNKNOWN, QTY=1| EXPEDIUM POLYAXIAL SCREWS: (B)(4), QTY=2 |