MAUDE Adverse Event Report: LDR MÉDICAL 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
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.
Event or Problem Description
It was reported that a cage broke intra-operatively while the mating plate was being removed.The cage was removed and replaced with a competitive construct to complete the procedure without patient impacts.
Event or Problem Description
It was reported that a cage broke intra-operatively while the mating plate was being removed because the plate would not seat into the cage.The cage and plate were removed and replaced with a competitive construct to complete the procedure without patient impacts.Device evaluation by the manufacturer found the plate had also fractured.This is report one of two for this event.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation product was returned.Inspection revealed that the cage is clearly cracked.Potential cause root cause was unable to be determined.This event could possibly be attributed to off-axis forces applied during insertion.Dhr review per dhr review, the parts were likely conforming when they left zimmer biomet control.Device use this device is used for treatment.Reference report 3004788213-2022-00008.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: ROI-C IMPLANT 14X14 H7
• 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: 13022006
• Report Number: 3004788213-2021-00168
• Device Sequence Number: 4704440
• Product Code: OVE
• UDI-Device Identifier: 03662663016070
• UDI-Public: (01)03662663016070(11)190701(17)240701(10)732123
• 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: 2021
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 01/26/2022

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: 07/01/2024
• Device Catalogue Number: MC1312P
• Device Lot Number: 73123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2021
• 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: 11/25/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 66 KG