FDA Adverse Event
Injury
Summary report: N
FIBERGRAFT BG PUTTY, 11CC
MDR report key: 16341499
·
Received February 9, 2023
Report
- Report Number
- 3011015097-2023-00001
- Event Type
- Injury
- Date Received
- February 9, 2023
- Date of Event
- January 13, 2023
- Report Date
- February 9, 2023
- Manufacturer
- PROSIDYAN, INC.
- Product Code
- MQV
- UDI-DI
- 00856879006731
- PMA / PMN Number
- K170306
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED TO THE MANUFACTURER ON (B)(6) 2023 THAT A PATIENT COMPLAINED THEY COULD FEEL SOMETHING HARD UNDER THE SKIN. ADDITIONAL INFORMATION WAS PROVIDED ON JANUARY 30, 2023 INDICATING THAT SECONDARY SURGERY WAS PERFORMED TO EXPLORE AND REMOVE THE PRODUCT FROM THE SOFT TISSUE. THE SURGEON ALSO STATED THAT THE PATIENT HAD A PALPABLE, PAINFUL MASS THAT CORRELATED WITH THE PRODUCT IN THE SOFT TISSUE ON THE LATERAL CALCANEUS. BASED ON THE INFORMATION PROVIDED BY THE SURGEON, IT WAS DETERMINED THAT THIS EVENT SHOULD BE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1608124 | FIBERGRAFT BG PUTTY, 11CC | RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE | MQV | PROSIDYAN, INC. | 78000110 | 2109011 | 00856879006731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |