MAUDE Adverse Event Report: LDR MEDICAL ROI-C IMPLANT HOLDER BODY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	MC9001R-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
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 roi-c procedure, while trying to disengage the implant from the implant holder, the hook on the implant holder broke off and remained in the cage.They tried to remove it, but there wasn't enough space or grip to grab it.So they decided to leave it in place and close the patient.The hook tip remains stuck in the cervical cage between vertebrae.
Event or Problem Description
It was reported that during an roi-c procedure, while trying to disengage the implant from the implant holder, the hook on the implant holder broke off and remained in the cage.They tried to remove it, but there wasn't enough space or grip to grab it.So they decided to leave it in place and close the patient.The hook tip remains stuck in the cervical cage between vertebrae.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the hook has fractured off.Root cause: this event could be attributed to wear through multiple uses over time, or excessive forces applied during use.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.

• Brand Name: ROI-C IMPLANT HOLDER BODY
• 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: 22098466
• Report Number: 3004788213-2025-00031
• Device Sequence Number: 7445778
• Product Code: LXH
• UDI-Device Identifier: 03662663043168
• UDI-Public: (01)03662663043168(10)2297403A/05
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MC9001R-1
• Device Lot Number: 2297403A/05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic