FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3103116
·
Received May 9, 2013
Report
- Report Number
- 6000034-2013-00876
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- March 27, 2013
- Report Date
- September 11, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE PATIENT WAS ADMINISTERED A COURSE OF ANTIBITOCS, TYPE AND DOSAGE NOT REPORTED, (B)(6), 2013 TO TREAT SOFT TISSUE ISSUESTHIS REPORT IS FILED AUG 1, 2013. IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA IN AN OR (DATE NOT REPORTED), IN ORDER TO REMOVE THE ABUTMENT AND EXCISE GRALUNLATED TISSUE AROUND THE IMPLANT SIDE. THE PATIENT WAS EQUIPPED WITH A COVER SCREW DURING THE SAME PROCEDURE. THE FIXTURED STAYED INSITU AT ALL TIMES.THIS REPORT IS FILED NOVEMBER 28, 2013. IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT RECEIVED KENNELOG INJECTIONS FOR SOFT TISSUE OVERGROWTH. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204281 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | 93332 | 126829 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |