FDA Adverse Event
Injury
Summary report: N
NEURO SCREWS,CROSS-PIN,SELF-DRILLING, 1.5X4MM, 5/P
MDR report key: 2063791
·
Received April 15, 2011
Report
- Report Number
- 8010177-2011-00125
- Event Type
- Injury
- Date Received
- April 15, 2011
- Date of Event
- March 24, 2011
- Report Date
- March 25, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- JEY
- PMA / PMN Number
- K031659
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT AVAILABLE FOR RETURN. INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
PATIENT HAD INFECTION AROUND INCISION SITE DUE TO PATIENT NEGLIGENCE. REMOVED PRODUCT TO EXPLORE INFECTION SITE, SURGEON INDICATED THAT THE PRODUCT WAS NOT AT FAULT FOR INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURO SCREWS,CROSS-PIN,SELF-DRILLING, 1.5X4MM, 5/P | IMPLANT | JEY | STRYKER OSTEOSYNTHESIS FREIBURG | NA | 0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |