N
Patient 1
PRODUCT COMPLAINT # (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 9296857
- MDR report key
- 9296857
- Report number
- 1818910-2019-115246
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-10-15
- Date received
- 2019-11-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KARA DITTY-BOVARD
- Address
- 700 ORTHOPAEDIC DRIVE WARSAW IN 46581 US
- Phone
- 610-610-6107
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SUMMIT CALCAR PLANER-LARGE | HIP INSTRUMENTS : REAMERS | DEPUY ORTHOPAEDICS INC US | LYS | 257004200 | AY1001 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-11-08 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE SURGEON SAID THE CALCAR PLAINER WERE DULL. NO SURGICAL DELAY.