FDA Adverse Event
Injury
Summary report: N
BA400 ABUTMENT 10MM
MDR report key: 7612174
·
Received June 18, 2018
Report
- Report Number
- 6000034-2018-01299
- Event Type
- Injury
- Date Received
- June 18, 2018
- Date of Event
- May 4, 2018
- Report Date
- October 9, 2018
- Manufacturer
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Product Code
- MAH
- PMA / PMN Number
- K121317
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON JUNE 19, 2018. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT DETAILS HAVE NOW BEEN REPORTED, AS UPDATED IN SECTIONS. THIS REPORT IS SUBMITTED OCTOBER 19, 2018.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION SURROUNDING THE IMPLANT SITE, RESULTING IN THE DECISION TO EXPLANT THE DEVICE ON (B)(6) 2018. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451971 | BA400 ABUTMENT 10MM | COCHLEAR BAHA CONNECT SYSTEM | MAH | COCHLEAR BONE ANCHORED SOLUTIONS AB | 93335 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |