FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3122986
·
Received May 21, 2013
Report
- Report Number
- 6000034-2013-00926
- Event Type
- Injury
- Date Received
- May 21, 2013
- Date of Event
- May 7, 2013
- Report Date
- May 21, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
CORRECTION: PER THE CLINIC, THE ABUTMENT WAS REMOVED AND A SLEEPER FIXTURE WAS PLACED ON (B)(6) 2013; NO SKIN DEBRIDEMENT OCCURRED AS PREVIOUSLY REPORTED. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013, TO DEBRIDE SKIN TISSUE AROUND THE IMPLANT SITE. DURING THE SAME PROCEDURE, A SLEEPER FIXTURE WAS PLACED. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223589 | FLANGE FIXTURE AND ABUTMENT | PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Required Intervention |