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	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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, the hook of the roi-c inserter broke off and remained attached to the cage slot, resulting in its retention inside the body.As a result, both the cage and the blade were removed.There was a 30 minute delay associated with this event, but no reported patient impact.
Additional Manufacturer Narrative
Corrections in d4: lot & udi numbers, d9, and h3.Additional information in h4.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 intra-operatively, the hook of the roi-c inserter broke off and remained attached to the cage slot, resulting in its retention inside the body.As a result, both the cage and the blade were removed.There was a 30 minute delay associated with this event, but no reported patient impact.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h6: investigation type, findings, and conclusions.A review of the dhr was conducted and found there was one non-conformance associated with this lot related to a functional issue between the adjustable stop and knob.However this functional issue is not related to this complaint issue of a fractured hook and there were no further indications of a manufacturing issue.Visual inspection revealed the hook has fractured from the device.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for roi-c implant holder (pn mc9091r) for the failure of fracture.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.
Event or Problem Description
It was reported that intra-operatively, the hook of the roi-c inserter broke off and remained attached to the cage slot, resulting in its retention inside the body.As a result, both the cage and the blade were removed.There was a 30 minute delay associated with this event, but no reported patient impact.

• 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 ; 3035018506
• MDR Report Key: 23381133
• Report Number: 3004788213-2025-00059
• Device Sequence Number: 21093943
• Product Code: LXH
• UDI-Device Identifier: 03662663043649
• UDI-Public: (01)03662663043649(10)0333027801/18
• 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,Followup
• Report Date (Section B): 02/15/2026

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: 0333027801/18
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/21/2025; 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• 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
• Patient Ethnicity: Non Hispanic