FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 2981532
·
Received February 27, 2013
Report
- Report Number
- 6000034-2013-00320
- Event Type
- Injury
- Date Received
- February 27, 2013
- Report Date
- May 9, 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
PER THE CLINIC, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2013, TO EXCISE SCAR/SKIN OVERGROWTH TISSUE. THIS REPORT IS FILED (B)(4) 2013.
Additional Manufacturer Narrative · 1
(B)(4). THE IMPLANTED DEVICE REMAINS. THIS REPORT IS FILED JULY 2, 2013.
Additional Manufacturer Narrative · 1
(B)(4) IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED AN OVERGROWTH OF TISSUE AROUND THE IMPLANT SITE AS A RESULT OF KELOID SCARRING. THE PATIENT WAS TREATED WITH STEROID INJECTIONS (TYPE AND AMOUNT NOT REPORTED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83697 | FLANGE FIXTURE AND ABUTMENT | LXB, PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |