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

Model Number	N/A
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/14/2019
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: 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.
Additional 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 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.The device did not cause or contribute to a death or serious injury.

• Brand Name: ROI-A ANCHORING PLATE M
• 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: 8757473
• Report Number: 3004788213-2019-00202
• Device Sequence Number: 1680294
• Product Code: OVD
• UDI-Device Identifier: 03662663010986
• UDI-Public: 03662663010986
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: IR2008T
• Device Lot Number: 286515/2
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 07/03/2019
• 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