MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LONG ANCHORING PLATE; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1006T
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2020
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.Reference reports: 3004788213-2020-00203 and 3004788213-2020-00205.
Event or Problem Description
It was reported an roi-c plate at c5 bent upon impaction causing the cage to crack.Both the cage and plates were explanted.The same size cage and plate were used to replace the explanted devices.After using the awl, the top plate at c5 bent again.The surgeon removed the bent plate and left the cage with one plate of fixation.There was no known patient impact.This is report one of three for this event.
Event or Problem Description
It was reported an roi-c plate at c5 bent upon impaction causing the cage to crack.Both the cage and plates were explanted.The same size cage and plate were used to replace the explanted devices.After using the awl, the top plate at c5 bent again.The surgeon removed the bent plate and left the cage with one plate of fixation.There was no known patient impact.This is report one of three for this event.
Additional Manufacturer Narrative
Additional information in h6: method, results, and conclusions.This follow-up report is being submitted to relay additional information.Device evaluation: the products were not returned and no photos, intra-op/post-op images, or surgical notes were provided, so an evaluation is unable to be performed.The complaint is non-verifiable for the reported failure.Dhr review and related actions: per dhr review, the parts were likely conforming when it left zimmer biomet control.No actions required.This event is not related to any product holds.Device use: this devices are used for treatment.Potential cause this event could possibly be attributed to off-axis forces capable of overcoming the material properties applied during impaction.With the given information, the definitive cause cannot be determined.

• Brand Name: ROI-C LONG ANCHORING PLATE
• 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: 10927418
• Report Number: 3004788213-2020-00202
• Device Sequence Number: 19643451
• Product Code: OVE
• UDI-Device Identifier: 03662663016988
• UDI-Public: (01)03662663016988(17)240601(10)772841
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K151934
• 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): 12/29/2020

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: 06/01/2024
• Device Catalogue Number: MC1006T
• Device Lot Number: 772841
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1