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

Catalog Number	MC1005T
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
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 3004788213-2023-00009 through 3004788213-2023-00011.
Event or Problem Description
It was reported that the roi-c plates had a hard time passing through the implant holder and caused the cage to break.The cage was removed and replaced with a second cage, but it also broke while trying to advance the plates.This cage was also removed and the holder and plates were switched out.The second set of plates were successfully installed into the third cage using the second holder.An awl was not needed and the patient did not have hard bone.There were no patient impacts.This is report three of three for this event.
Additional Manufacturer Narrative
Corrections in d4: udi number.Additional information in d4: expiration date, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned, and photos were not provided.Device evaluation unable to be completed.Root cause: root cause was unable to be determined.This event could possibly be attributed to inserting the plates at an angle or not using a starter awl.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that the roi-c plates had a hard time passing through the implant holder and caused the cage to break.The cage was removed and replaced with a second cage, but it also broke while trying to advance the plates.This cage was also removed and the holder and plates were switched out.The second set of plates were successfully installed into the third cage using the second holder.An awl was not needed and the patient did not have hard bone.There were no patient impacts.This is report three of three for this event.

• Brand Name: ROI-C 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, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16362563
• Report Number: 3004788213-2023-00011
• Device Sequence Number: 15268541
• Product Code: OVE
• UDI-Device Identifier: 03662663016971
• UDI-Public: (01)03662663016971(17)270301(10)289294/5
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151934
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: Other
• Device Catalogue Number: MC1005T
• Device Lot Number: 289294/5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic