FDA Adverse Event
Injury
Summary report: N
FLANGE FIXTURE AND ABUTMENT
MDR report key: 3020186
·
Received March 25, 2013
Report
- Report Number
- 6000034-2013-00521
- Event Type
- Injury
- Date Received
- March 25, 2013
- Report Date
- May 23, 2013
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- LXB
- PMA / PMN Number
- K955713
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
CORRECTION: THE CORRECT CATALOG # IS 92132; 90305 AS PREVIOUSLY REPORTED. (B)(4). IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A TRAUMA TO HIS HEAD SUBSEQUENTLY KNOCKING HIS ABUTMENT LOOSE. THE PATIENT UNDERWENT A PROCEDURE TO EXCISE THE EXCESS SKIN AROUND THE IMPLANTED SITE ON (B)(6) 2013; DURING THE PROCEDURE A NEW ABUTMENT WAS PLACED. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121971 | FLANGE FIXTURE AND ABUTMENT | LXB, PRODUCT CODE: LXB | LXB | COCHLEAR BONE ANCHORED SOLUTIONS AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |