FDA Adverse Event
Injury
Summary report: N
EXPEDIUM SINGLE INNER SET SCREW
MDR report key: 2143063
·
Received June 23, 2011
Report
- Report Number
- 1526439-2011-00112
- Event Type
- Injury
- Date Received
- June 23, 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
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEPUY SPINE HAS REQUESTED THE RETURN OF THE DEVICE FOR EVALUATION. A FOLLOW UP MEDWATCH REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.
Description of Event or Problem · 1
INTERNATIONAL AFFILIATE REPORTS THAT REVISIONS SURGERY WAS PERFORMED DUE TO LOOSENING OF THE SET SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXPEDIUM SINGLE INNER SET SCREW | SPINAL FIXATION DEVICE | NKB | DEPUY SPINE, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | EXPEDIUM POLY SCREW, (B)(4), QTY = 1| EXPEDIUM POLY SCREW, (B)(4), QTY = 4| EXPEDIUM PREBENT ROD, (B)(4), QTY = 2| EXPEDIUM SI SET SCREW, (B)(4), QTY = 4 |