MAUDE Adverse Event Report: LDR MEDICAL IMPLANT ROI-C LORDOSE; LDR SPINE ROI-C CERVICAL CAGE SYSTEM

Catalog Number	MC1443P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.(b)(4).
Event or Problem Description
It was reported that during the procedure the anchoring plate was difficult to insert and the cage broke.The plate and cage were removed and replaced with alternates to complete the case with no reported patient harm.This is report one of two for this event.
Additional Manufacturer Narrative
Additional information in b4, d10, g4, g7, h2, h3, h4, h6: methods, results, and conclusion codes.The returned device was evaluated.Visual inspection revealed that the cage is fractured on the end where the plate is inserted.The complaint is confirmed.A review of the manufacturing records did not identify any issues related to this failure which would have contributed with this event.As this failure is regularly occurring with known causes and impacts, a summary investigation was completed.The fracture occurs due to the plate applying force on the strut that is on the anterior side of the groove.The force can come from the plate entering hard bone and bending from the resistance, from the cage moving posteriorly after the plate has been partially or totally inserted, or from the first plate not being fully inserted or some other obstruction in the groove.
Event or Problem Description
It was reported that during the procedure the anchoring plate was difficult to insert and the cage broke.The plate and cage were removed and replaced with alternates to complete the case with no reported patient harm.This is report one of two for this event.

• Brand Name: IMPLANT ROI-C LORDOSE
• Common Device Name: LDR SPINE ROI-C CERVICAL CAGE SYSTEM
• Manufacturer (Section D): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 9789977
• Report Number: 3004788213-2020-00016
• Device Sequence Number: 16716484
• Product Code: OVE
• UDI-Device Identifier: 03662663016544
• UDI-Public: (01)03662663016544(17)240301(10)70356
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K150765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2020

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: 03/01/2024
• Device Catalogue Number: MC1443P
• Device Lot Number: 70356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1