FDA Adverse Event
Malfunction
Summary report: N
ANATOMAGE INC.
MDR report key: 7470880
·
Received April 27, 2018
Report
- Report Number
- 3008272529-2018-00015
- Event Type
- Malfunction
- Date Received
- April 27, 2018
- Date of Event
- January 2, 2018
- Report Date
- January 10, 2018
- Manufacturer
- ANATOMAGE INC.
- Product Code
- NDP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IMPLANT SITE #23 WAS THE WEAKEST POINT OF THE GUIDE DUE TO LESS COVERAGE. DOCTOR MIGHT HAVE APPLIED TOO MUCH PRESSURE ON THE GUIDE WHEN A TISSUE PUNCH WAS BEING DONE THROUGH IT. AS A RESULT, GUIDE FRACTURED FROM SITE #23.
Description of Event or Problem · 1
WHEN DOCTOR WAS PERFORMING A TISSUE PUNCH THROUGH THE GUIDE AT SITE 23, THE SLEEVE POPPED OUT AND THE GUIDE FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310515 | ANATOMAGE INC. | SURGICAL GUIDE | NDP | ANATOMAGE INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |