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

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

This medwatch is submitted to send the initial report of this complaint.Product was not returned yet, no evaluation could be performed.The review of the device history records is ongoing.Investigation still in progress.

Event Description

Roi-a: broken cage.Surgeon has broken two cages during surgery, according to information provided, this event was related to an instrument malfunction.Surgical technique was followed.Additional information was requested.Investigation ongoing.

Manufacturer Narrative

This mdr report was submitted in error.There is no information available that suggests that there was a malfunction of the device.The device did not cause or contribute to a death or serious injury.

Event Description

This mdr report was submitted in error.There is no information available that suggests that there was a malfunction of the device.The device did not cause or contribute to a death or serious injury.

• Brand Name: ROI-A ANCHORING PLATE M
• 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: 8757473
• MDR Text Key: 149923380
• Report Number: 3004788213-2019-00202
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 03662663010986
• UDI-Public: 03662663010986
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Model Number: N/A
• Device Catalogue Number: IR2008T
• Device Lot Number: 286515/2
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1