MAUDE Adverse Event Report: LDR MÉDICAL ROI-A MEDIAN IMPLANT PXL : 27X30 H 12MM 14; ROI-A ALIF CAGE SYSTEM

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); 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
H3 "no information" checked in error.The implant was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the dhr did not find any issues which would have contributed to this event.
Event or Problem Description
It was reported that during surgery, two roi-a cages broke upon insertion of the anchoring plate.There was no reported patient or surgical impact.This is report one of two for this event.

• Brand Name: ROI-A MEDIAN IMPLANT PXL : 27X30 H 12MM 14
• Common Device Name: ROI-A ALIF CAGE SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8757467
• Report Number: 3004788213-2019-00201
• Device Sequence Number: 2728816
• Product Code: MAX
• UDI-Device Identifier: 03662663011419
• UDI-Public: 03662663011419
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: N/A
• Device Catalogue Number: IR2541P
• Device Lot Number: 17-171936
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 04/16/2020
• 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