FDA Adverse Event
Malfunction
Summary report: N
REJUVENATE STEM INSERTER
MDR report key: 1850015
·
Received September 27, 2010
Report
- Report Number
- 2249697-2010-01280
- Event Type
- Malfunction
- Date Received
- September 27, 2010
- Date of Event
- September 8, 2010
- Report Date
- September 8, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT "THE INSERTER WOULDN'T FIT INTO THE STEM".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REJUVENATE STEM INSERTER | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |