FDA Adverse Event
Injury
Summary report: N
HAMMERLOCK
MDR report key: 5868225
·
Received August 11, 2016
Report
- Report Number
- 1649263-2016-00035
- Event Type
- Injury
- Date Received
- August 11, 2016
- Date of Event
- January 8, 2013
- Report Date
- August 4, 2016
- Manufacturer
- BIOMEDICAL ENTERPRISES, INC.
- Product Code
- HTY
- UDI-DI
- 00810633020043
- PMA / PMN Number
- K091951
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO BME.
Description of Event or Problem · 1
ON (B)(6) 2011 HAMMERLOCK (HLXMA) WAS INSERTED DURING HAMMERTOE CORRECTION. IMPLANT WAS LATER REMOVED ON OR AROUND (B)(6) 2013 DUE TO INFECTION. DURING EXPLANTATION OR PRIOR, IMPLANT LEG WAS BROKEN AND ALL DEBRIS COULD NOT BE EXTRACTED. IT IS UNCONFIRMED WHETHER INFECTION WAS DUE TO IMPLANTED DEVICE. IF ADDITIONAL INFORMATION PERTINENT TO THIS INCIDENT IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522113 | HAMMERLOCK | HTY, PIN, FIXATION, SMOOTH | HTY | BIOMEDICAL ENTERPRISES, INC. | HLXMA | UNK | 00810633020043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |