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 9881206
- MDR report key
- 9881206
- Report number
- 1818910-2020-09281
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-11
- Date received
- 2020-03-25
- 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 DR. 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 | ATTUNE RP TIBIAL IMPACTOR | ATTUNE INSTRUMENTS : IMPACTORS | DEPUY IRELAND - 9616671 | HWA | 2544-01-004 | 254401004 | AU3664789 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-25 | 0 |
Event Narratives#
D
Patient 1
IMPACTOR BROKE UPON IMPACTION OF FINAL IMPLANT.