FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 1251713
·
Received December 3, 2008
Report
- Report Number
- 6000034-2008-00690
- Event Type
- Injury
- Date Received
- December 3, 2008
- Date of Event
- October 1, 2008
- Report Date
- November 7, 2008
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS, AB
- Product Code
- LXB
- PMA / PMN Number
- K984162
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS A FINAL REPORT, FILED DECEMBER 03, 2008.
Description of Event or Problem · 1
PER THE AUDIOLOGIST, THE PATIENT'S PRIMARY FLANGE FIXTURE WITH ABUTMENT FELL OUT THREE DAYS POST-OP WHEN HER MOTHER ATTEMPTED TO REMOVE THE HEALING CAP. THE PATIENT WAS BILATERALLY IMPLANTED WITH SLEEPER FIXTURES ON BOTH SIDES. THE CONTRALATERAL SIDE IS REPORTEDLY HEALING "WELL".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLANGE FIXTURE AND ABUTMENT | LXB | COCHLEAR BONE ANCHORED SOLUTIONS, AB | 90430 | 605587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 MO | Required Intervention |