MAUDE Adverse Event Report: LDR MEDICAL ROI-C LORDOTIC IMPLANT 14X17 H7; LDR SPINE ROI-C CERVICAL CAGE SYSTEM

Catalog Number	MC1433P
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2024
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 during an acdf surgery after the cervical cage was inserted, a crack was noted in the upper portion of the implant.Following surgical guide the surgeon drilled off areas for removal.The implant was effectively destroyed during removal and the pieces were retrieved and discarded.A new implant of the same size was then placed with only a 20 minute delay.The patient was not harmed.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the device was not returned and no photos were provided, so an evaluation is unable to be performed.Root cause: a definitive root cause cannot be determined with the information provided.A potential cause of the cage fracturing before the anchoring plates are installed is the selected cage size being too tall for the disc space, resulting in excessive forces being applied on the cage during installation.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s 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.
Event or Problem Description
It was reported that during an acdf surgery after the cervical cage was inserted, a crack was noted in the upper portion of the implant.Following surgical guide the surgeon drilled off areas for removal.The implant was effectively destroyed during removal and the pieces were retrieved and discarded.A new implant of the same size was then placed with only a 20 minute delay.The patient was not harmed.

• Brand Name: ROI-C LORDOTIC IMPLANT 14X17 H7
• Common Device Name: LDR SPINE ROI-C CERVICAL CAGE SYSTEM
• Manufacturer (Section D): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 20729614
• Report Number: 3004788213-2024-00086
• Device Sequence Number: 9161960
• Product Code: OVE
• UDI-Device Identifier: 03662663016483
• UDI-Public: (01)03662663016483(17)260101(10)81423
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 02/18/2025

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: 12/31/2025
• Device Catalogue Number: MC1433P
• Device Lot Number: 81423
• 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: 11/19/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• 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 Age: 48 YR
• Patient Sex: Female
• Patient Weight: 149 KG
• Patient Ethnicity: Non Hispanic