FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 4031077
·
Received August 22, 2014
Report
- Report Number
- 0002249697-2014-03226
- Event Type
- Malfunction
- Date Received
- August 22, 2014
- Date of Event
- July 29, 2014
- Report Date
- July 29, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- HTQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN BROACH. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT STEM FELL LOWER THEN THE BROACH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509098 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | INSTRUMENT | HTQ | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |