FDA Adverse Event
Injury
Summary report: N
GORILLA PLATING SYSTEM
MDR report key: 14539235
·
Received May 30, 2022
Report
- Report Number
- 3008650117-2022-00059
- Event Type
- Injury
- Date Received
- May 30, 2022
- Date of Event
- April 19, 2022
- Report Date
- August 17, 2022
- Manufacturer
- PARAGON 28, INC.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
LIMITED INFORMATION RECEIVED SO FAR HOWEVER A REVISION SURGERY WAS REPORTED. INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative · 0
(ANNEX C) 4247 - THIS COMPLAINT WAS NOT ESCALATED TO ROOT CAUSE ANALYSIS. (ANNEX D) 4316 - THIS COMPLAINT WAS NOT ESCALATED TO ROOT CAUSE ANALYSIS.
Description of Event or Problem · 0
A REVISION SURGERY OCCURRED AND SCREWS BACKING OF A PLATE WAS REPORTED. LIMITED INFORMATION RECEIVED REASONABLY SUGGESTS A REPORTABLE EVENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT SOME SCREWS BACKED OUT OF A MTP PLATE. A REVISION SURGERY WAS CONDUCTED AND ALL HARDWARE WERE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1599026 | GORILLA PLATING SYSTEM | SCREWS | HWC | PARAGON 28, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |