MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORDOTIC COATED IMPLANT 14 X 17 H5; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
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.Reference report 3004788213-2021-00033.
Event or Problem Description
It was reported that while the surgeon was installing the second plate into a cage at level c4/5, the cage broke and detached from the inserter.The surgeon had prepped the path of the second plate with the use of an awl to make a path for it.This was unsuccessful.The plate and cage were removed from the patient and the surgery was completed with another cage and plates of the same sizes.There was no patient impact.This is report two of two for this event.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.This report is relaying additional information.Device evaluation: the cage was cracked.Potential cause: root cause was unable to be determined.This event could possibly be attributed to wear of the implant holder through use over time or multiple sterilization cycles.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.Device use: this device is used for treatment.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 while the surgeon was installing the second plate into a cage at level c4/5, the cage broke and detached from the inserter.The surgeon had prepped the path of the second plate with the use of an awl to make a path for it.This was unsuccessful.The plate and cage were removed from the patient and the surgery was completed with another cage and plates of the same sizes.There was no patient impact.This is report two of two for this event.

• Brand Name: ROI-C LORDOTIC COATED IMPLANT 14 X 17 H5
• 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, n/a 10300 ; FR 10300
• MDR Report Key: 11589062
• Report Number: 3004788213-2021-00034
• Device Sequence Number: 11807746
• Product Code: OVE
• UDI-Device Identifier: 03662663023474
• UDI-Public: (01)03662663023474(17)251001(10)81263
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: 10/01/2025
• Device Model Number: N/A
• Device Catalogue Number: CMC1431P
• Device Lot Number: 81263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Weight: 70