MAUDE Adverse Event Report: LDR MEDICAL ROI-A MEDIAN IMPLANT PXL : 27X30 H 10MM 6 DEG.; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	IR2522P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10: roi-a implant holder threaded rod (part # ir9280r-1 lot # 510248203) fractured intra-operatively.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 intra-operatively, an roi-a plate was difficult to insert, and this resulted in the roi-a cage fracturing in the disc space.The implants were removed and another cage was installed without further complications.There was no patient harm, but this did result in a procedural delay of unspecified length.This is report one of two for this event.
Additional Manufacturer Narrative
H6: additional method code: 4109.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the device was not returned, however photos were provided which show that the spacer has fractured.Root cause: this event could possibly be attributed to excessive forces applied to the anchoring plate during insertion, possibly due to difficulty inserting into hard bone.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.Reference report 3004788213-2025-00030.
Event or Problem Description
It was reported that intra-operatively, an roi-a plate was difficult to insert, and this resulted in the roi-a cage fracturing in the disc space.The implants were removed and another cage was installed without further complications.There was no patient harm, but this did result in a procedural delay of unspecified length.This is report one of two for this event.

• Brand Name: ROI-A MEDIAN IMPLANT PXL : 27X30 H 10MM 6 DEG.
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 22097891
• Report Number: 3004788213-2025-00029
• Device Sequence Number: 8354064
• Product Code: MAX
• UDI-Device Identifier: 03662663011273
• UDI-Public: (01)03662663011273(17)291101(10)M87837
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K153495
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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 Catalogue Number: IR2522P
• Device Lot Number: M87837
• 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: 05/28/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic