FDA Adverse Event
Malfunction
Summary report: N
SPEED
MDR report key: 5548791
·
Received April 5, 2016
Report
- Report Number
- 1649263-2016-00012
- Event Type
- Malfunction
- Date Received
- April 5, 2016
- Date of Event
- February 1, 2015
- Report Date
- March 15, 2016
- Manufacturer
- BIOMEDICAL ENTERPRISES, INC.
- Product Code
- JDR
- UDI-DI
- 00810633020159
- PMA / PMN Number
- K142292
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, SHOULD THE DEVICE BE RETURNED OR ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
SPEED (SE-131513) WAS INSERTED APPROPRIATELY DURING LAPIDUS PROCEDURE (B)(6) 2014. FOLLOW-UP X-RAY IN (B)(6) 2015 REVEALED THAT IMPLANT HAD BROKEN AFTER PATIENT REPORTED TRIPPING. PATIENT HAS NOT REQUIRED REVISION SURGERY, NOR REMOVAL OF BROKEN IMPLANT. 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 |
|---|---|---|---|---|---|---|---|
| 202418 | SPEED | SE-131513 | JDR | BIOMEDICAL ENTERPRISES, INC. | SE-131513 | BMESE1350028C | 00810633020159 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |