MAUDE Adverse Event Report: LDR MEDICAL ROI-C IMPLANT 14X14 H7; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1312P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Establishment name: (b)(6).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 report 3004788213-2020-00148.
Event or Problem Description
It was reported that during the procedure the cage and anchoring plate broke.They were removed, and replaced with alternates to complete the case.There were no reported patient impacts.This is report one of two for the event.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The complaint is confirmed for 1 roi-c implant 14x14 h6mm (pn mc1312p) and 1 roi-c anchoring plate (pn mc1005t) for the reported failure of a damaged roi-c cage and insertion piece.The cause of the damage cannot be determined at this time since there is no information available regarding how the cage and plates were being used or handled at the time of the damage, and the products were not returned for evaluation.Per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any previous actions.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Corrections in b5, d9, and h3.Additional information in h6: component, impact, investigation type, and findings.Device evaluation visual inspection revealed a plate is jammed in the cage and the cage has fractured.Device use these devices are 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 during the procedure the cage and anchoring plate broke.They were removed and replaced with alternates to complete the case.There were no reported patient impacts.This is report one of two for the event.

• Brand Name: ROI-C IMPLANT 14X14 H7
• Common Device Name: ROI-C TITANIUM-COATED IMPLANT SYSTEM
• Manufacturer (Section D): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: florence maily ; quartier eurpoe de l'quest; 5, rue de berlin; sainte-savine, na ; 33382803
• MDR Report Key: 10678228
• Report Number: 3004788213-2020-00142
• Device Sequence Number: 3028882
• Product Code: OVE
• UDI-Device Identifier: 03662663016070
• UDI-Public: (01)03662663016070(17)220701(10)60030C127
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2022

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: 07/01/2022
• Device Catalogue Number: MC1312P
• Device Lot Number: 60030C127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/28/2020; 04/29/2022
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 10/29/2020; 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 72 KG