FDA Adverse Event
Other
Summary report: N
HOWMEDICA MIX KIT I TM PRODUCT OF STRYKER I
MDR report key: 1865227
·
Received October 7, 2010
Report
- Report Number
- 8010177-2010-00368
- Event Type
- Other
- Date Received
- October 7, 2010
- Date of Event
- September 7, 2010
- Report Date
- September 8, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- GXP
- PMA / PMN Number
- K060763
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT AVAILABLE FOR RETURN. INTERNAL INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A FOREIGN MATERIAL IN THE STERILE PACKAGE. THE SURGEON USED A SPARE PRODUCT INSTEAD OF IT AND THE PROCEDURE WAS COMPLETED W/O ANY PROBLEMS AND DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOWMEDICA MIX KIT I TM PRODUCT OF STRYKER I | IMPLANT | GXP | STRYKER ORTHOPAEDICS MAHWAH | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |