N
Patient 1
UDI NUMBER: NI. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.
MAUDE MDR 8869851
- MDR report key
- 8869851
- Report number
- 3012447612-2019-00332
- Event key
- 0
- Event type
- 3
- Date received
- 2019-08-07
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. ASHLEY MCPHERSON
- Address
- 10225 WESTMOOR DR. NA WESTMINSTER CO 80021 US
- Phone
- 303-303-3034
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PITUITARY RONGEUR BLACK 3MM LATERAL | RONGEUR | ZIMMER BIOMET SPINE INC. | HTX | NA | 8733-7153 | IM00281 | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-08-07 | 0 |
Event Narratives#
D
Patient 1
A BROKEN RONGEUR WAS RETURNED TO THE MANUFACTURER. NO INFORMATION IS AVAILABLE REGARDING WHEN THE BREAKAGE OCCURRED OR ANY POSSIBLE PATIENT IMPACTS.