MAUDE Adverse Event Report: LDR MÉDICAL ROI-C COATED CAGE H5 14X14MM; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
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.Review of the device history records and traceability shows no evidence on a device issue that may have caused this event.Additional information was requested.Investigation still in progress.
Event or Problem Description
Roi-c ti: implant broke during surgery.Breaking the cage during surgery.No impact for patient.No additional medical intervention.No delay.Surgical technique was followed.Additional information was requested.Investigation ongoing.
Additional Manufacturer Narrative
The returned cage was examined.Visual inspection found that part of the front of the cage has fractured off at one of the plate interfaces.The cause of this event can likely be attributed to damage that occurred during insertion of the anchoring plate.It is likely that the cage was misaligned within the disc space such that during impaction of the anchoring plate, an unexpected off-axis force was placed on the cage resulting in its fracture.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 the implant broke during surgery.There was no impact to patient and no additional medical intervention reported.

• Brand Name: ROI-C COATED CAGE H5 14X14MM
• Common Device Name: ROI-C TITANIUM-COATED IMPLANT SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8731000
• Report Number: 3004788213-2019-00189
• Device Sequence Number: 2637063
• Product Code: OVE
• UDI-Device Identifier: 03662663023122
• UDI-Public: 03662663023122
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2020

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: 07/01/2021
• Device Model Number: N/A
• Device Catalogue Number: CMC1311P
• Device Lot Number: 49700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 06/19/2020
• 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