HUNTER TENDON ROD
Received Nov 10, 2016
Report 1043534-2016-00117 · MDR key 6093863
Device
Generic name
Small Joint Component
Manufacturer
Wright Medical Technology, Inc.Model number
TRX0-0000Lot number
NI
Product problems
- Contamination of Device Ingredient or Reagent
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. THE INVESTIGATION IS CONSIDERED CLOSED.
Additional Manufacturer Narrative
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
PER DJERBI ET AL 2016, "PROGNOSTIC FACTORS IN TWO-STAGE FLEXOR TENDON RECONSTRUCTION: IS IT POSSIBLE TO PREDICT SURGICAL FAILURE?", ONE CASE OF INFECTION OF THE SILICONE ROD IN BETWEEN THE TWO OPERATIONS WAS REPORTED.