N
Patient 1
(B)(4). 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 8361429
- MDR report key
- 8361429
- Report number
- 3012447612-2019-00085
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-01-18
- Date received
- 2019-02-22
- 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 | IN SITU ROD BENDER, LEFT (DIA. 3.8MM) | BENDER | ZIMMER BIOMET SPINE INC. | HXW | NA | 07.01771.002 | 62874477 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-22 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE TIP OF AN IN-SITU ROD BENDER WAS FOUND BROKEN OFF AFTER THE DEVICE WENT THROUGH STERILE PROCESSING AT THE END OF A PROCEDURE. IT IS UNKNOWN WHEN THE TIP OF THE DEVICE BROKE OFF. THERE WERE NO REPORTS OF PATIENT OR SURGICAL IMPACTS ASSOCIATED WITH THIS EVENT.