N
Patient 1
THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED.
MAUDE MDR 9903418
- MDR report key
- 9903418
- Report number
- 0001526350-2020-00287
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-12
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. CHRISTINA ARNT
- Address
- 56 E. BELL DRIVE WARSAW IN 46582 US
- Phone
- 574-574-5745
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ZIMMER AIR DERMATOME | DERMATOME | ZIMMER SURGICAL, INC. | GFD | 00880100100 | N/A | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE UNIT WAS NOT GETTING ENOUGH SPEED DURING SURGERY. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.