MAUDE Adverse Event Report: KALITED DIRECT DBA KALITEC MEDICAL COSMOLOCK; PEDICLE SCREW SYSTEM

Catalog Number 11-SSE-7540

Device Problems Break (1069); Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Weakness (2145); No Code Available (3191)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

This report was initially filed on (b)(6) 2017.At that time the report was being filed following a retrospective review of the complaint file.It was initially determined that no report was required based on the failure being attributed to misuse and no patient injury resulted from the failure.Upon review of the file it was noted that the event occurred during a revision surgery necessitated by the placement of the screw.Because of the revision surgery this should have been identified as a potential patient injury event and that medical intervention was required to ensure serious patient injury was not sustained.The report was initiated on (b)(6) 2017 and the first acknowledgement email was received on that date.It was thought that the report was accepted into the maude data base.During a recent subsequent inspection it was noted that the maude data base did not hold the report.Cdrh emdr was contacted via email.They were provided a copy of the completed report (report number 3009165919-2017-00003), a copy of the acknowledgement email, and a copy of a screen shot of the axway synchrony gateway interchange showing under "my fda submissions" displaying the report.They investigated and determined that the report was not completely processed.They requested the report be resubmitted.This report is that resubmission.

Event Description

On (b)(6) 2016 surgery was conduced and the surgeon placed the device in the patient.On (b)(6) 2016 the patient reported weakness and the surgeon surmised that the trajectory of one of the placed screws was incorrect leading to the reported weakness.The surgeon conducted revision surgery on (b)(6) 2016 to correct the misplacement of the screw.After removing the locking cap and the rod from the screw in question and while attempting to reposition the screw located at s1 the surgeon broke the screw saddle.The screw and all of its components were retrieved from the patient.A replacement screw was placed at a different trajectory to elevate the initial condition.On the failed screw it was determined that the screw saddle had locked in position by the force applied to the saddle washer by the rod and locking cap.This is a normal condition and occurs by design.In attempting to free the saddle in order to position the screwdriver in the screw head, the surgeon over angulated the saddle using the instruments as a fulcrum.This forced the head of the screw to separate from the screw body.The screw was not returned for the investigation.The revision surgery was successful and the patient had no other reported issues.

• Brand Name: COSMOLOCK
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): KALITED DIRECT DBA KALITEC MEDICAL; 618 e. south street; suite 500; orlando, fl
• Manufacturer (Section G): RAM PRECISION INDUSTRIES; 11125 yankee road; dayton, oh
• Manufacturer Contact: keith cannan ; 618 e. south street; suite 500; orlando, fl ; 5452063103
• MDR Report Key: 9887996
• MDR Text Key: 240418730
• Report Number: 3009165919-2020-00001
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11-SSE-7540
• Device Lot Number: BBGR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention