FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3924547
·
Received July 10, 2014
Report
- Report Number
- 6000034-2014-00913
- Event Type
- Injury
- Date Received
- July 10, 2014
- Date of Event
- June 11, 2014
- Report Date
- June 13, 2014
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K121317
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AROUND THE IMPLANT SITE. CLEANING OF THE SITE AND TREATMENT WITH TOPICAL CREAM (DURATION AND DOSAGE NOT REPORTED) WAS ATTEMPTED; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. FURTHER TREATMENT WITH ANTIBITOICS (TYPE, DURATION AND DOSAGE NOT REPORTED) TEMPORARELY RESOLVED THE ISSUE, HOWEVER; INFLAMMATION AROUND THE IMPLANT SITE RECURRED.THE PATIENT UNDERWENT A PROCEDURE (DATE NOT REPORTED) TO EXCISE, CAUTERISE AND DEBRIDE THE SITE; HOWEVER THE ISSUE COULD NOT BE RESOLVED.THE FIXTURE AND ABUTMENT REMAINED INSITU AT ALL TIMES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 404459 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |