MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORDOTIC IMPLANT 14X17 H8; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1434P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a roi-c cage and plate broke when the surgeon put in the long anchoring plate; the awl was not used to prepare the bone and the patient had hard bone.The cage and plate were removed and replaced to complete the procedure without patient impact.This is report two of two for this event.
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference report 3004788213-2022-00019.
Additional Manufacturer Narrative
Device evaluation: visual inspection revealed the cage has fractured and one of the returned plates has deformation damage to the end of the plate.The other returned plate shows no signs of damage.Potential cause: root cause was unable to be determined.This event could possibly be attributed to not using the awl to prepare the bone or due to unknown patient factors.Dhr review: per dhr review, the parts were likely conforming when they left zimmer biomet control.Device use: this device is used for treatment.
Event or Problem Description
It was reported that a roi-c cage and plate broke when the surgeon put in the long anchoring plate; the awl was not used to prepare the bone and the patient had hard bone.The cage and plate were removed and replaced to complete the procedure without patient impact.This is report two of two for this event.

• Brand Name: ROI-C LORDOTIC IMPLANT 14X17 H8
• 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: 13929295
• Report Number: 3004788213-2022-00020
• Device Sequence Number: 12344125
• Product Code: OVE
• UDI-Device Identifier: 03662663016490
• UDI-Public: (01)03662663016490(17)251001(10)80421
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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: 10/01/2025
• Device Catalogue Number: MC1434P
• Device Lot Number: 80421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• 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: 02/28/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• 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: Male