MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT ROI-C 12X14 H5; LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch is submitted to send the initial report of this complaint.Attempts to obtain additional information have been made and no answer has been provided yet.The review of traceability shows no evidence on a device issue that may have an impact on this case.Product was not returned yet, no evaluation could be performed.Investigation still in progress.Not returned to manufacturer yet.
Event or Problem Description
Roi-c: broken cage during impaction of the anchoring plate.Breakage of the implant during impaction of the anchor.No impact for patient.No delay.According to the reporter surgical technique was followed.Additional information was requested.Investigation ongoing.
Event or Problem Description
It was reported that a cage broke while impacting the first anchoring plate.The surgery was completed with another implant.There was no impact to the patient reported.
Additional Manufacturer Narrative
The returned cage was evaluated.Visual inspection found that part of the anterior portion of the device has fractured off.A review of the dhr did not find any issues which would have contributed to this event.As the damage occurred during insertion of the anchoring plate, it is possible 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 it's fracture; however, the initial positioning of the cage is unknown.As such, a cause cannot be conclusively determined.

• Brand Name: IMPLANT ROI-C 12X14 H5
• Common Device Name: LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8731227
• Report Number: 3004788213-2019-00191
• Device Sequence Number: 2167952
• Product Code: ODP
• UDI-Device Identifier: 03662663016278
• UDI-Public: 03662663016278
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K091088
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 05/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MC1341P
• Device Lot Number: 65400
• 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: 04/02/2020
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 05/01/2020
• 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