FDA Adverse Event
Injury
Summary report: N
PATIENT SPECIFIC TALUS SPACER
MDR report key: 19064963
·
Received April 8, 2024
Report
- Report Number
- 3008650117-2024-00023
- Event Type
- Injury
- Date Received
- April 8, 2024
- Report Date
- April 8, 2024
- Manufacturer
- PARAGON 28, INC
- Product Code
- QNN
- PMA / PMN Number
- H200001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
UPDATED/CORRECTED: D6B H6 (ALL UPDATED/CORRECTED).
Additional Manufacturer Narrative · 0
3191 - AN ADVERSE EVENT (E.G. PATIENT HARM) APPEARS TO HAVE OCCURRED, BUT THERE DOES NOT APPEAR TO HAVE BEEN A PROBLEM WITH THE DEVICE. THE INJURY IS DEVICE RELATED WITH NO ALLEGED DEFICIENCY IN A PARAGON 28 MEDICAL DEVICE. THE HEALTHCARE PROVIDER NOTED THE SUBJECT DID NOT DISCLOSE A MEDICAL HISTORY OF NEUROPATHY PRIOR TO THE PATIENT SPECIFIC TOTAL TALUS PROCEDURE.
Description of Event or Problem · 0
A PATIENT SPECIFIC TALUS SPACER CLINICAL STUDY IDENTIFIED THE SUBJECT HAD WOUND DEHISCENCE (LIMB ISCHEMIA) APPROXIMATELY 5 WEEKS POST DEVICE IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103968 | PATIENT SPECIFIC TALUS SPACER | TITANIUM PATIENT SPECIFIC TALUS SPACER, SMALL | QNN | PARAGON 28, INC | AOPSTSXXXXS-TI | AOCIA1768 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female | Other |