FDA Adverse Event
Malfunction
Summary report: N
REJUVENATE STEM INSERTER
MDR report key: 2251391
·
Received August 10, 2011
Report
- Report Number
- 2249697-2011-01177
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- July 18, 2011
- Report Date
- July 21, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "REJUVENATE STEM INSERTER DID NOT ENGAGE THE IMPLANT." THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.
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 | Other |