D
Patient 1
PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS ON (B)(6) 2020. IT IS UNKNOWN WHETHER THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
MAUDE MDR 9881618
- MDR report key
- 9881618
- Report number
- 6000034-2020-00948
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-27
- 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#
- Report source
- D
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FLANGE FIXTURE ST 4MM | COCHLEAR BAHA CONNECT SYSTEM | COCHLEAR BONE ANCHORED SOLUTIONS AB | LXB | 90432 | 90432 | NI | * | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-25 | 0 | 1. R |