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

Catalog Number	MC9001R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
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 the hook at the tip of a roi-c implant holder fractured intra-operatively when the doctor impacted the cage and when he tried to remove the piece that locks the cage.It is not believed that the piece was retained in the patient since it did not show up in any x-rays.
Additional Manufacturer Narrative
Corrections in d4: lot number & udi number, d9, and h3.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 the hook at the tip of a roi-c implant holder fractured intra-operatively when the doctor impacted the cage and when he tried to remove the piece that locks the cage.It is not believed that the piece was retained in the patient since it did not show up in any x-rays.
Event or Problem Description
It was reported that the hook at the tip of a roi-c implant holder fractured intra-operatively when the doctor impacted the cage and when he tried to remove the piece that locks the cage.It is not believed that the piece was retained in the patient since it did not show up in any x-rays.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.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: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to 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
• 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: 20610154
• Report Number: 3004788213-2024-00085
• Device Sequence Number: 8143820
• Product Code: LXH
• UDI-Device Identifier: 03662663043168
• UDI-Public: (01)03662663043168(10)610323901/03
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2025

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: MC9001R
• Device Lot Number: 610323901/03
• Was Device Available for Evaluation?: Yes
• 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; Not provided
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 03/24/2025; 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2017
• 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
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic