FDA Adverse Event
Injury
Summary report: N
HAMMERLOCK 1.1
MDR report key: 4663546
·
Received April 3, 2015
Report
- Report Number
- 1649263-2015-00004
- Event Type
- Injury
- Date Received
- April 3, 2015
- Report Date
- April 3, 2015
- Manufacturer
- BIOMEDICAL ENT., INC.
- Product Code
- HTY
- PMA / PMN Number
- K131640
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
ON (B)(6) 2015, A BME DISTRIBUTOR RECEIVED AN X-RAY FROM A SALES REP WHICH REVEALED A HAMMERLOCK 1.1 (MODEL AND SIZE UNAVAILABLE) INSERTED AT AN ANGLE. ONE OF THE IMPLANT LEGS BROKE THE CORTICAL WALL AND WAS OUTSIDE OF THE BONE. AS FUSION HAD ALREADY TAKEN PLACE, THE SURGEON CLIPPED OFF THE PROTRUDING IMPLANT LEG AND DID NOT EXPLANT THE DEVICE. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 220581 | HAMMERLOCK 1.1 | PIN, FIXATION, SMOOTH, 21 CFR 888.3040 | HTY | BIOMEDICAL ENT., INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |