FDA Adverse Event
Malfunction
Summary report: N
CORTEX SCREW S.T. 4.5X36MM
MDR report key: 1813244
·
Received August 18, 2010
Report
- Report Number
- 8031020-2010-00105
- Event Type
- Malfunction
- Date Received
- August 18, 2010
- Date of Event
- July 21, 2010
- Report Date
- July 30, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- KTW
- PMA / PMN Number
- K001614
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, THE INNER PACKAGE HAD ADHERED TO OUTER PACKAGE WHEN NURSE OPENED OUTER PACKAGE, INNER PACKAGE WAS OPENED AT THE SAME TIME, AND THE SCREW FELL TO THE FLOOR. THE SURGEON USED SPARE PRODUCT INSTEAD. THE SURGERY WAS COMPLETED WITHOUT PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORTEX SCREW S.T. 4.5X36MM | IMPLANT | KTW | STRYKER OSTEOSYNTHESIS SELZACH | NA | U22629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |