FDA Adverse Event
Injury
Summary report: N
EXPEDIUM SINGLE-INNIER SETSCREW
MDR report key: 1844608
·
Received September 23, 2010
Report
- Report Number
- 1526439-2010-00134
- Event Type
- Injury
- Date Received
- September 23, 2010
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- KWQ
- PMA / PMN Number
- K062174
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ANOMALIES WERE FOUND WITH THE RETURNED DEVICES AND NO CONNECTION COULD BE MADE BETWEEN THE REPORTED EVENT AND THE IMPLANTS USED IN THE CASE. A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. CARE MUST BE TAKEN TO ENSURE THAT THE CONSTRUCT FULLY TIGHTENED AND ASSEMBLED PROPERLY. CONSTRUCT LOOSENING IS LISTED AS A POSSIBLE ADVERSE OUTCOME IN THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE.
Description of Event or Problem · 1
THE PT WAS OPERATED IN AUGUST, BUT 10 DAYS AFTER THE DISTAL BLOCKER WAS OFF THE SCREW HEAD AND THE PT WAS REVISED. AS SURGICAL INTERVENTION WAS REQUIRED, AN MDR IS FILED TO DOCUMENT THIS EVENT. DEVICE 1. SEE ALSO: 1526439-2010-00135.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXPEDIUM SINGLE-INNIER SETSCREW | SPINAL FIXATION DEVICE | KWQ | DEPUY SPINE, INC. | NA | AKPBN9 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |