FDA Adverse Event
Injury
Summary report: N
ADHERUS AUTOSPRAY DURAL SEALANT
MDR report key: 24188521
·
Received January 27, 2026
Report
- Report Number
- 3005920920-2026-00002
- Event Type
- Injury
- Date Received
- January 27, 2026
- Date of Event
- January 5, 2026
- Report Date
- April 24, 2026
- Manufacturer
- HYPERBRANCH MEDICAL TECHNOLOGY, INC
- Product Code
- NQR
- UDI-DI
- 30897146002019
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 0
IT WAS REPORTED THAT TWO SEPARATE PATIENTS UNDERGOING REVISION LUMBAR LAMINECTOMY SURGERIES AND HAD TO BE BROUGHT BACK FOR CSF LEAKS. IN THE ORIGINAL PROCEDURE, A CSF LEAK WAS IDENTIFIED AND TREATED WITH ADHERUS AUTOSPRAY ET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155035 | ADHERUS AUTOSPRAY DURAL SEALANT | DURAL SEALANT | NQR | HYPERBRANCH MEDICAL TECHNOLOGY, INC | 04256187 | 30897146002019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |