FDA Adverse Event
Injury
Summary report: N
MANTIS REDUX BLOCKER
MDR report key: 18785021
·
Received February 26, 2024
Report
- Report Number
- 3004024955-2024-00002
- Event Type
- Injury
- Date Received
- February 26, 2024
- Date of Event
- January 27, 2024
- Report Date
- April 24, 2024
- Manufacturer
- STRYKER SPINE-US
- Product Code
- NKB
- UDI-DI
- 04546540671431
- PMA / PMN Number
- K092631
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H6 CODING HAS BEEN UPDATED TO REFLECT COMPLETION OF THE INVESTIGATION.
Additional Manufacturer Narrative · 0
FOUR POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS DEVICE: ER2, EYA, FER, AND GPZ.
Description of Event or Problem · 0
A PATIENT WAS REVISED TO ADDRESS A MIGRATED MANTIS REDUX BLOCKER AT L3 APPROXIMATELY SEVEN WEEKS AFTER IMPLANTATION.
Description of Event or Problem · 0
A PATIENT WAS REVISED TO ADDRESS A MIGRATED MANTIS REDUX BLOCKER AT L3 APPROXIMATELY SEVEN WEEKS AFTER IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1565651 | MANTIS REDUX BLOCKER | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM | NKB | STRYKER SPINE-US | ER2 | 04546540671431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Male | Required Intervention |