N
Patient 1
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
MAUDE MDR 7544094
- MDR report key
- 7544094
- Report number
- 1818910-2018-60477
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-04-25
- Date received
- 2018-05-25
- 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. KARA DITTY-BOVARD
- Address
- 1210 WARD AVENUE WEST CHESTER PA 19380 US
- Phone
- 610-610-6103
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FEM RASP TRIAL CO/FJD T8 | OTHER PRODUCTS | DEPUY FRANCE SAS - 3003895575 | HTR | L93208 | 5220070 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-05-25 | 0 |
Event Narratives#
D
Patient 1
TWO PROUD CORAIL IMPLANTS YESTERDAY DUE TO RASP IMPLANT MISMATCH. AT THIS TIME IT'S UNKNOWN WHAT SIZE OF BROACH/RASP WERE USED DURING THESE CASES. ALL ARE BEING REPORTED AT THIS TIME ON LINKED PCS. THE TWO STEM ARE REPORTED TWO STEMS ARE REPORTED IN TWO SEPARATE LINKED PCS. DOE: (B)(6) 2018.
N
Patient 1
PRODUCT COMPLAINT # : (B)(4). THE DEVICE WAS RETURNED, AND THE FAILURE MODE WAS CONFIRMED DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
N
Patient 1
PRODUCT COMPLAINT # : (B)(4). THE DEVICE WAS RETURNED, AND THE FAILURE MODE WAS CONFIRMED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.