FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 2993606
·
Received March 7, 2013
Report
- Report Number
- 6000034-2013-00389
- Event Type
- Injury
- Date Received
- March 7, 2013
- Date of Event
- February 22, 2013
- Report Date
- February 22, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED AN OVERGROWTH OF SKIN TISSUE AROUND THE IMPLANT SITE.THE PATIENT UNDERWENT SURGERY ON (B)(6) 2013, DURING WHICH THE ABUTMENT WAS REMOVED, AND A NEW ABUTMENT WAS ATTACHED TO THE PATIENT'S SECOND FIXTURE. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96962 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | N/A | 005CMC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Required Intervention |