FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3871925
·
Received June 13, 2014
Report
- Report Number
- 6000034-2014-00837
- Event Type
- Injury
- Date Received
- June 13, 2014
- Report Date
- August 4, 2014
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE PATIENT UNDERWENT A PROCEDURE (B)(6) 2014 TO ACCESS THE IMPLANT SITE AND A NEW ABUTMENT WAS PLACED. THE IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT WAS ADMINISTERED A KENALOG INJECTION (DATE NOT REPORTED) AT THE IMPLANT SITE DUE TO SORENESS AND A SOFT TISSUE REACTION. ON (B)(6), 2014 THE PATIENT UNDERWENT A PROCEDURE TO EXCHANGE THE ABUTMENT, AT WHICH TIME IT WAS NOTED THAT THE FIXTURE WAS LOOSE. THE ABUTMENT WAS REMOVED AND THE SITE WAS SUTURED CLOSED. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350644 | FLANGE FIXTURE AND ABUTMENT | LXB, PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | N/A | 126756 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |