FDA Adverse Event
Injury
Summary report: N
HAMMERLOCK
MDR report key: 2375266
·
Received December 13, 2011
Report
- Report Number
- 1649263-2011-00002
- Event Type
- Injury
- Date Received
- December 13, 2011
- Report Date
- November 7, 2011
- Manufacturer
- BIOMEDICAL ENTERPRISES, INC.
- Product Code
- HTY
- PMA / PMN Number
- K091951
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A (B)(6) FEMALE IN A MAJOR METROPOLITAN AREA WHO WALKED EXTENSIVELY.
Description of Event or Problem · 1
HAMMERLOCK IMPLANT WAS USED TO CORRECT HAMMERTOE CONDITION. THE IMPLANT BROKE PRIOR TO JOINT FUSION AND THE SURGEON PERFORMED F/U SURGERY TO REMOVE THE BROKEN IMPLANT AND CORRECT THE HAMMERTOE CONDITION WHICH HAD RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HAMMERLOCK | HTV INTRAMEDULLARY BONE FASTENER | HTY | BIOMEDICAL ENTERPRISES, INC. | HLXSA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |