MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG MED H14MM 30X39MM 14; INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT

Model Number	N/A
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Roi-a: anchor plate didn't deploy.As reported , a 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.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 min.The patient was not harmed in any way during this procedure.Additional information was requested.Investigation ongoing.
Additional Manufacturer Narrative
Corrections to all fields.This mdr report was submitted in error.There is no information available that suggests that there was a malfunction of the device.Additionally, the device did not contribute to a death or serious injury.
Event or Problem Description
This mdr report was submitted in error.There is no information available that suggests that there was a malfunction of the device.Additionally, the device did not contribute to a death or serious injury.

• Brand Name: ROI-A CAG MED H14MM 30X39MM 14
• Common Device Name: 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: 8825404
• Report Number: 3004788213-2019-00247
• Device Sequence Number: 2337100
• Product Code: OVD
• UDI-Device Identifier: 03662663014243
• UDI-Public: 03662663014243
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2024
• Device Model Number: N/A
• Device Catalogue Number: IR5341P
• Device Lot Number: 18-280428
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR