FDA Adverse Event
Malfunction
Summary report: N
SCORPIO TS DISTAL BLOCK
MDR report key: 2081792
·
Received April 14, 2011
Report
- Report Number
- 2249697-2011-00466
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 21, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K994128
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "NO SCREW IN THE PACKAGE REFERENCE (B)(4), #5, 10 MILLIMETER AUGMENT, LOT CODE # BJTP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIO TS DISTAL BLOCK | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | BJTP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |