FDA Adverse Event
Other
Summary report: N
ZUMA-C IMPLANT 15X13X7MM LORDOTIC
MDR report key: 2358046
·
Received November 29, 2011
Report
- Report Number
- 2032593-2011-00014
- Event Type
- Other
- Date Received
- November 29, 2011
- Date of Event
- September 22, 2011
- Report Date
- November 29, 2011
- Manufacturer
- SEASPINE, INC.
- Product Code
- ODP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTER STATED A ACDF WAS PERFORMED AND THE PT BELIEVES SHE IS ALLERGIC TO THE IMPLANT. X-RAYS DO NOT INDICATE AN INFECTION OR ANY IRREGULAR SWELLING. SURGEON HAS REQUESTED A PLATE TO TAPE TO THE PT'S SKIN. HE WOULD LIKE TO DO A FEW BASIC TESTS BEFORE REMOVING IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZUMA-C IMPLANT 15X13X7MM LORDOTIC | ZUMA-C | ODP | SEASPINE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |