FDA Adverse Event
Malfunction
Summary report: N
ACUFEX, MOSAIC PLASTY-TUBULAR CHISEL 3.5MM
MDR report key: 225327
·
Received May 24, 1999
Report
- Report Number
- 1219602-1999-00033
- Event Type
- Malfunction
- Date Received
- May 24, 1999
- Date of Event
- March 19, 1999
- Manufacturer
- SMITH & NEPHEW INC. ENDOSCOPY DIVISION
- Product Code
- KDG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE SURGEON USED THE DEVICE TO HARVEST BONE PLUG, HE FOUND THAT THE PLUG WAS DISCOLORED. SURGEON CLEANED THE PLUG PRIOR TO INSERTING IT INTO THE PT. NO PT INJURY HAS RESULTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUFEX, MOSAIC PLASTY-TUBULAR CHISEL 3.5MM | BONE CHISLE | KDG | SMITH & NEPHEW INC. ENDOSCOPY DIVISION | NA | 365009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |