FDA Adverse Event
Injury
Summary report: N
EXPEDIUM 6.35 SINGLE-INNIE SET SCREW, TI
MDR report key: 2011570
·
Received March 7, 2011
Report
- Report Number
- 1526439-2011-00033
- Event Type
- Injury
- Date Received
- March 7, 2011
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- MNH
- PMA / PMN Number
- K062174
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SET SCREW REMAINS IN THE PT AND IS NOT AVAILABLE FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS THE LOT CODE IS UNK. A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. 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.
Description of Event or Problem · 1
INTERNATIONAL AFFILIATE REPORTS THAT ON PRESENTATION AT 3 MONTH POST OP CLINIC IN (B)(6), X-RAYS HIGHLIGHTED THAT THE SET SCREW HAD BACKED OUT OF THE HEAD OF THE SCREW. THE DEVICE REMAINS IN THE PT AND IS NOT AVAILABLE FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXPEDIUM 6.35 SINGLE-INNIE SET SCREW, TI | SPINAL FIXATION DEVICE | MNH | DEPUY SPINE, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |