FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3831320
·
Received May 24, 2014
Report
- Report Number
- 6000034-2014-00764
- Event Type
- Injury
- Date Received
- May 24, 2014
- Date of Event
- April 24, 2014
- Report Date
- May 13, 2014
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K984162
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS ON (B)(6) 2014 DUE TO INFECTION AT THE IMPLANT SITE, SUBSEQUENT TO A PROCEDURE ON (B)(6), 2014 TO ACCESS THE FIXTURE SITE UNDER GENERAL ANESTHESIA TO PLACE A NEW ABUTMENT. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309682 | FLANGE FIXTURE AND ABUTMENT | LXB, PRODUCT CODE | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | 134189 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Required Intervention |