FDA Adverse Event
Injury
Summary report: N
TELESCOPINT ROUND DIAMOND
MDR report key: 19166063
·
Received April 23, 2024
Report
- Report Number
- 2025102-2024-00002
- Event Type
- Injury
- Date Received
- April 23, 2024
- Date of Event
- April 1, 2024
- Report Date
- April 23, 2024
- Manufacturer
- BRASSELER USA
- Product Code
- DZP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BRASSELER IS REPORTING THIS INCIDENT IN AN ABUNDANCE OF CAUTION DUE TO USER ERROR.
Description of Event or Problem · 0
ON THE LAMINECTOMY PORTION OF THE PROCEDURE THE SURGEON WAS STRUGGLING TO BURR THE BONE. AFTER A BIT OF BURRING, THE BURR GOT EXTREMELY HOT. WHEN IRRIGATION WAS SPLASHED ON THE BURR TIP, IT SIZZLED. THIS PATIENT HAS VERY DELICATE, SOFT BONE, SO THE SURGEON COULD NOT KEEP BURRING WITHOUT CAUSING MORE HARM. THE SURGEON WAS ABLE TO CONTINUE BY USING A CUTTING BURR INSTEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1083227 | TELESCOPINT ROUND DIAMOND | DIAMOND BUR | DZP | BRASSELER USA | NX5B3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Required Intervention |