FDA Adverse Event
Malfunction
Summary report: N
NEXTRA HAMMERTOE CORRECTION SYSTEM
MDR report key: 8392392
·
Received March 5, 2019
Report
- Report Number
- 3009540749-2019-00001
- Event Type
- Malfunction
- Date Received
- March 5, 2019
- Date of Event
- December 14, 2018
- Report Date
- February 6, 2018
- Manufacturer
- NEXTREMITY SOLUTIONS, INC.
- Product Code
- HWC
- UDI-DI
- 00817701020011
- PMA / PMN Number
- K110445
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO PRODUCTION ANOMALIES. NEXTREMITY SOLUTIONS, INC. MADE GOOD FAITH EFFORT TO PROVIDE INFORMATION FOR RETURN AND TO REQUEST RETURN OF THE PRODUCT INVOLVED IN THIS EVENT. THE PARTS WERE NOT RETURNED TO THE MANUFACTURER AND THERE FOR NO EVALUATION OF THE PARTS WAS CONDUCTED.
Description of Event or Problem · 1
THE SURGEON REPORTED FAILURE OF THE FEMALE(PROXIMAL) 4.5MM NEXTRA COMPONENT TO ENGAGE WITH THE MALE (MIDDLE) COMPONENT ON TWO SEPARATE NX-4532K DEVICES WITHIN THE SAME SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY AFTER THE REPORTED DEVICE FAILURES. A SURGICAL DELAY OF GREATER THAN 30 MINUTES WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184216 | NEXTRA HAMMERTOE CORRECTION SYSTEM | PHALANX BONE SCREW IMPLANT | HWC | NEXTREMITY SOLUTIONS, INC. | NX-4532K | 168117318B | 00817701020011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |