N
Patient 1
(B)(4). MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
MAUDE MDR 6275846
- MDR report key
- 6275846
- Report number
- 9610612-2017-00034
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-12-25
- Date received
- 2017-01-25
- 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. NICOLE BROYLES
- Address
- 615 LAMBERT POINTE DRIVE HAZELWOOD MO 63042 US
- Phone
- 314-314-3145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | YASARGIL TI PERM STD-CLIP BAYO 12MM | CRANIAL IMPLANTS | AESCULAP AG | HCH | FT759T | FT759T | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-25 | 0 | 1. O |
Event Narratives#
D
Patient 1
COUNTRY OF COMPLAINT: (B)(6). DURING AN OPERATION THE DEVICE CROSSED OVER AFTER CLIPPING. THE SURGEON TOOK OFF THE CLIP AND USED ANOTHER CLIP TO COMPLETE THE PROCEDURE. THERE WAS AN HOUR DELAY IN SURGERY DUE TO CHANGING THE CLIP.