FDA Adverse Event
Malfunction
Summary report: N
HAMMERLOCK
MDR report key: 3704404
·
Received January 17, 2014
Report
- Report Number
- 1649263-2014-00001
- Event Type
- Malfunction
- Date Received
- January 17, 2014
- Report Date
- January 20, 2014
- Manufacturer
- BIOMEDICAL ENT., INC.
- Product Code
- HTY
- PMA / PMN Number
- K091951
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 1
A SURGEON REPORTED BY E-MAIL THE BREAKAGE OF 4 IMPLANTS OVER A PERIOD OF TIME. INFO IS BEING GATHERED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46125 | HAMMERLOCK | HAMMERLOCK | HTY | BIOMEDICAL ENT., INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |