FDA Adverse Event
Summary report: N
EXP SINGLE SET SCREW 5.5 SS
MDR report key: 2112502
·
Received April 6, 2011
Report
- Report Number
- 1526439-2011-00047
- Date Received
- April 6, 2011
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- KWP
- PMA / PMN Number
- K041119
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PLEASE REFER TO 1526439-2011-00045 FOR DETAILS.
Description of Event or Problem · 1
PLEASE REFER TO 1526439-2011-00045 FOR DETAILS. DEVICE 3 OF 3. FOR ADD'L PRODUCTS SEE: 1526439-2011-00045 AND 1526439-2011-00046.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXP SINGLE SET SCREW 5.5 SS | FIXATION DEVICE | KWP | DEPUY SPINE, INC. | NA | RE103072 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |