MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT ROI-C 14X15,5 H4,5; LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

Catalog Number	MC1320P
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
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.
Event or Problem Description
It was reported that an roi-c cage was not well-positioned then it moved anteriorly and into the cortical rim of the vertebral body while the superior plate was being installed.The cage was removed and replaced to complete the procedure.There was a 10 minute delay and no impact to the patient.
Event or Problem Description
It was reported that an roi-c cage was not well-positioned then it moved anteriorly and into the cortical rim of the vertebral body while the superior plate was being installed.The cage was removed and replaced to complete the procedure.There was a 10 minute delay and no impact to the patient.
Additional Manufacturer Narrative
Device evaluation: product was not returned and no photos were provided.Device evaluation unable to be performed.Root cause: root cause was unable to be determined.This event could possibly be attributed to improper placement initially or improper cage selection.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.

• Brand Name: IMPLANT ROI-C 14X15,5 H4,5
• Common Device Name: LDR SPINE CERVICAL INTERBODY FUSION 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: 16484877
• Report Number: 3004788213-2023-00021
• Device Sequence Number: 17604586
• Product Code: OVE
• UDI-Device Identifier: 03662663016124
• UDI-Public: (01)03662663016124(17)270401(10)C92251
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 05/19/2023

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: Health Professional
• Device Catalogue Number: MC1320P
• Device Lot Number: C92251
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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 Sex: Unknown