Catalog Number 39-MT-0301 |
Device Problems
Difficult to Insert (1316); Fitting Problem (2183)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/01/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Evaluation of product from the same lot found the root cause is attributed to mis-labeling of product returned to distribution.A capa was initiated for investigation and corrective action.This report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2018-00051 / 00052).
|
|
Event Description
|
It was reported that during a procedure on an unknown date in (b)(6), upon attempts to insert the rod it was identified that it would not fit in two (2) of the modular polyaxial tulip assembiles (39-mt-0301).The two (2) screw/tulip assemblies were removed from the patient and replaced with other product readily available in the set.The removed screws/tulips were discarded at the hospital.There was no injury to the patient as a result of this malfunction.
|
|
Search Alerts/Recalls
|