N
Patient 1
(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
MAUDE MDR 8122013
- MDR report key
- 8122013
- Report number
- 1818910-2018-76848
- Event key
- 0
- Event type
- 3
- Date received
- 2018-12-01
- 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 | SLF TAPPING ROOF PILE SCRW20MM | BONE SCREWS AND PINS : SCREWS | DEPUY ORTHOPAEDICS INC US 1818910 | JDJ | 101140020 | D5LDH1000 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-12-01 | 0 | 1. R |
Event Narratives#
D
Patient 1
PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PULMONARY EMBOLISM.
N
Patient 1
PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.