FDA Adverse Event
Injury
Summary report: N
BARRICAID ACD
MDR report key: 20266319
·
Received September 20, 2024
Report
- Report Number
- 3006232063-2024-00037
- Event Type
- Injury
- Date Received
- September 20, 2024
- Date of Event
- August 22, 2024
- Report Date
- September 20, 2024
- Manufacturer
- INTRINSIC THERAPEUTICS, INC
- Product Code
- QES
- UDI-DI
- M906BARA810MM0
- PMA / PMN Number
- P160050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DESCRIPTION OF THE EVENTS DETAILED IN THIS MDR REPRESENT INTRINSIC THERAPEUTIC'S UNDERSTANDING AT THE TIME OF SUBMISSION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION ANOTHER FOLLOW-UP WILL BE COMPLETED. INTRINSIC THERAPEUTICS WILL CONTINUE TO MONITOR FOR UPDATES/TRENDS.
Description of Event or Problem · 0
THE SURGEON REPORTED TO INTRINSIC THAT THE PATIENT HAD REPORTED TO THEM, "3 YEARS POST-OP WITH ACUTE LEFT LEG PAIN AND RECURRENT HNP. HAD CALLED OFFICE A YEAR AGO WITH SHORT TERM LEFT LEG PAIN THAT RESOLVED AND DIDN'T FOLLOW UP FURTHER AT THAT TIME. PERFORMED REVISION LEFT L5S1 MLD. SMALL HNP VS. SCAR TISSUE FOUND. LIGAMENT OVER BARRICAID INTACT. FELT IMMEDIATE POST OP IMPROVEMENT"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1392878 | BARRICAID ACD | BARRICAID | QES | INTRINSIC THERAPEUTICS, INC | BAR-A8-10MM | 07212002 | M906BARA810MM0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female | Other |