MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT ROI-C 12X14 H6; 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	07/01/2019
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.Not returned to manufacturer yet.
Event or Problem Description
Roi-c : found that the fusion cage fractured.During surgery performed on (b)(6) 2019, surgeon found that the fusion cage fractured when the cage was filled with bone substitute.This cage was not used and not implanted in patient¿s body.Same reference was used to complete the surgery.No patient impact or surgery delay were reported.Investigation still in progress.
Additional Manufacturer Narrative
The device was returned; however, appropriate documentation was not provided by the reporter to allow for a complete investigation.As such, only a visual examination could be performed which concluded that the cage was indeed fractured; however, without being able to complete a physical evaluation, 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, a cage fractured while being filled with bone substitute.The cage was discarded and a new cage was used to complete the surgery.There was no patient or surgical impact reported.

• Brand Name: IMPLANT ROI-C 12X14 H6
• 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: 8835305
• Report Number: 3004788213-2019-00241
• Device Sequence Number: 11552954
• Product Code: ODP
• UDI-Device Identifier: 03662663016285
• UDI-Public: 03662663016285
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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: 08/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MC1342P
• Device Lot Number: 67287
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 04/30/2020
• 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