FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3127782
·
Received May 23, 2013
Report
- Report Number
- 6000034-2013-00962
- Event Type
- Injury
- Date Received
- May 23, 2013
- Date of Event
- May 7, 2013
- Report Date
- August 20, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PER THE SURGEON, THE PATIENT UNDERWENT A SECOND REVISION SURGERY ON (B)(6) 2013, TO EXCISE THE EXCESS SKIN AROUND THE ABUTMENT. DURING THE SAME PROCEDURE, THE ABUTMENT WAS EXCHANGED. (B)(6). THIS REPORT IS FILED OCTOBER 23, 2013. IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT SKIN OVERGROWTH AND TO DEBRIDE THE IMPLANT SITE. THE PATIENT WAS ADMINISTERED INJECTABLE STEROIDS AND ANTIBIOTICS (TYPES NOT REPORTED.) THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228288 | FLANGE FIXTURE AND ABUTMENT | LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Required Intervention |