FDA Adverse Event
Injury
Summary report: N
VBR CAGE
MDR report key: 14946744
·
Received July 6, 2022
Report
- Report Number
- MW5110727
- Event Type
- Injury
- Date Received
- July 6, 2022
- Date of Event
- December 9, 2020
- Report Date
- July 4, 2022
- Manufacturer
- ULRICH MEDICAL USA, INC.
- Product Code
- MQP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NJ, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
FUSION OF C4 TO C5 ON FRONT CAME LOOSE AND PERFORATED THE ESOPHAGUS. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1986138 | VBR CAGE | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE | MQP | ULRICH MEDICAL USA, INC. | |||
| 1986139 | UNION PLATE | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY | MQP | ULRICH MEDICAL USA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| L| O| H |