FDA Adverse Event
Injury
Summary report: N
SCORPIO-FLEX PS X3 TIB INSERT
MDR report key: 1910421
·
Received November 23, 2010
Report
- Report Number
- 2249697-2010-01586
- Event Type
- Injury
- Date Received
- November 23, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 2, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K051977
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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: "PT HAD REVISION DUE TO PAIN AND INSTABILITY. UPON REMOVAL OF THE POLY, THE SURGEON NOTICED THAT THE PS POST OF THE POLY WAS BROKEN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIO-FLEX PS X3 TIB INSERT | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | 8L3MKD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |