FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3180690
·
Received June 20, 2013
Report
- Report Number
- 6000034-2013-01102
- Event Type
- Injury
- Date Received
- June 20, 2013
- Date of Event
- June 5, 2013
- Report Date
- June 10, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, ON (B)(6) 2013, THE PATIENT REPORTED INFLAMMATION AND DRAINAGE AT THE IMPLANT SITE. THE PATIENT WAS PRESCRIBED Z-PACK AND BACTROBAN (AMOUNTS NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280787 | FLANGE FIXTURE AND ABUTMENT | LXB, PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |