MAUDE Adverse Event Report: LDR MEDICAL ROI-C LORDOTIC IMPLANT 12X15.5 H7; LDR SPINE ROI-C CERVICAL CAGE SYSTEM

Catalog Number	MC1453P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a piece of an roi-c cage broke while it was being installed into the disc space.The cage was removed and replaced to complete the procedure.There were no reported patient impacts.
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 piece of an roi-c cage broke while it was being installed into the disc space.The cage was removed and replaced to complete the procedure.There were no reported patient impacts.
Additional Manufacturer Narrative
Device evaluation: the device was not returned for evaluation and images were not provided, therefore an evaluation was unable to be completed.Root cause: a definitive root cause cannot be determined with the information provided.Dhr review: per dhr review, the part was likely conforming when it left highridge 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: ROI-C LORDOTIC IMPLANT 12X15.5 H7
• Common Device Name: LDR SPINE ROI-C CERVICAL CAGE SYSTEM
• Manufacturer (Section D): LDR MEDICAL; 5 rue de berlin; parc d'entreprises du grand tr; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de berlin; parc d'entreprises du grand tr; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17572014
• Report Number: 3004788213-2023-00071
• Device Sequence Number: 18334230
• Product Code: OVE
• UDI-Device Identifier: 03662663016605
• UDI-Public: (01)03662663016605(17)261001(10)C88509
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K150765
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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: 09/30/2026
• Device Catalogue Number: MC1453P
• Device Lot Number: C88509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic