MAUDE Adverse Event Report: LDR Medical ROI-C IMPLANT HOLDER; Orthopedic Manual Surgical Instrument

Catalog Number	MC9091R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a two-level roi-c procedure, the hook of the cage holder fractured.After the blade was inserted into the second level, the hook fractured while the surgeon was withdrawing the holder from the cage.The broken hook tip was ultimately found outside of the surgical site and there was no patient or procedural impact.
Additional Manufacturer Narrative
Corrections in d4: lot & udi numbers, d9, and h3.Additional information in h4 and h6: investigation type, findings, and conclusions.The dhr was reviewed and there are no indications of manufacturing issues which would have contributed to this event.The device was likely conforming when it left highridge¿s control.This event likely cannot be attributed to manufacturing or design related issues.An inspection of the part revealed the hook has fractured.The complaint is confirmed for roi-c implant holder for the failure of breaks/fractures.The failure could possibly be attributed to excessive and repeated lateral movements being applied beyond intended use.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 IMPLANT HOLDER
• Common Device Name: Orthopedic Manual Surgical Instrument
• 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 ; +1(303)501-8506
• MDR Report Key: 50332891
• Report Number: 3004788213-2026-00061
• Device Sequence Number: 12133221
• Product Code: LXH
• UDI-Device Identifier: 03662663043649
• UDI-Public: (01)03662663043649
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: Exempt
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: MC9091R
• Device Lot Number: 0305524737/09
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/23/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown