D
Patient 1
A PIECE OF THE IMPLANT BROKE OFF WHILE THE SURGEON WAS TRYING TO PLACE THE IMPLANT INTO THE PATIENT. THE SURGEON WAS ABLE TO PUT A SCREW THROUGH THE PIECE THAT BROKE OFF TO IMPLANT IT INTO THE PATIENT SEPARATELY.
MAUDE MDR 8479206
- MDR report key
- 8479206
- Report number
- 3009582362-2019-00005
- Event key
- 0
- Event type
- 3
- Date received
- 2019-04-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- BETH PASHKO
- Address
- PO BOX 585 30 SOUTH SATELLITE ROAD SOUTH WINDSOR CT 06074 US
- Phone
- 860-860-8606
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HTR-PEKK | FACIAL IMPLANT | OXFORD PERFORMANCE MATERIALS | KKY | PK621416 | 204686 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-04-03 | 0 | 1. O |