MAUDE MDR 9200779
- MDR report key
- 9200779
- Report number
- 2939274-2019-61550
- Event key
- 0
- Event type
- 3
- Date received
- 2019-10-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | PSI SD800.541 PEEK IMPLANT | PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | GXN | SD800.541 | SD800.541 | 17P4529 | | | | R
| N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2019-10-17 | 0 |
|
Event Narratives#
No narrative records found.