MAUDE Adverse Event Report: LDR MÉDICAL ROI-A IMPLANT HOLDER; INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT

Model Number N/A

Device Problems Break (1069); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

This medwatch is submitted to send the initial report of this complaint.Lot number of concerned device is not known.Attempts to obtain additional information have been made and no answer has been provided yet.So far, is not possible to perform the review of tracebaility and devices history records.Product was not returned yet, no evaluation could be performed.Investigation still in progress.

Event Description

Roi-a: ir9280r device malfunction.According to the description received, during a roi-a surgery , implant holder cotter pin came apart and fell into the wound.It was retrieved and taken out of patient.The threaded rod striped out of the implant so it could not be controlled.The shaft of the inserter broke off the wing guide so everytime the surgeon hit it with a mallet it bent over the guide making it impossible to deploy the blade after many attempts, the doctor decided it was best to remove the blade and cage an together.They burred portions of the anterior face of the implant per the surgical technique and removed the cage.This report is about the instrument breakage.The threaded rod was not coming out of the implant holder so the tech assembled the radd delivery system to implant the new cage and blades.Following the surgical technique the new cage and blades were implanted all together the case was delayed around 40-45.The patient was not harmed in any way during this procedure.The reported lot for instrument was not found in our records.Clarification requested.Investigation ongoing.

Event Description

This mdr is a duplicate of mdr # 3004788213-2019-00236-1.All non-required fields have been cleared of data.

Manufacturer Narrative

Corrections to all fields: this mdr is a duplicate of mdr # 3004788213-2019-00236-1.All non-required fields have been cleared of data.

• Brand Name: ROI-A IMPLANT HOLDER
• Type of Device: INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8825393
• MDR Text Key: 152173701
• Report Number: 3004788213-2019-00246
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IR9280R
• Device Lot Number: NO INFORMATION
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR