FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 4211649
·
Received October 29, 2014
Report
- Report Number
- 6000034-2014-01525
- Event Type
- Injury
- Date Received
- October 29, 2014
- Date of Event
- October 13, 2014
- Report Date
- October 15, 2014
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE. ON (B)(6) 2014, THE PATIENT WAS ADMINISTERED A LOCAL ANESTHETIC AND A BIOPSY PUNCH WAS USED TO ACCESS THE SITE. THE ABUTMENT WAS REMOVED AND REPLACED WITH A NEW ABUTMENT DURING THIS PROCEDURE. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692494 | FLANGE FIXTURE AND ABUTMENT | LXB: PRODUCT CODE | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |