MAUDE Adverse Event Report: LDR MEDICAL ROI-C LORDOTIC IMPLANT 14X17 H8; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1434P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the roi-c implant was placed in the patient and that upon malleting the first long plate, it became quite difficult to advance the last 2mm.The surgeon had to mallet quite hard to finish placing the long plate in the correct position.The second long plate was also more difficult than usual.The surgeon did not use the awls as he did not believe the bone was hard enough to merit them.Upon removal of the inserter handle, it was noted that a piece of the peek implant had chipped off.The surgeon tugged on the plates to ensure they were secure without the chipped piece and the implant was left in place.There was a 10-minute delay without impact on the patient.This is report one of two for this event.
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 roi-c implant was placed in the patient and that upon malleting the first long plate, it became quite difficult to advance the last 2mm.The surgeon had to mallet quite hard to finish placing the long plate in the correct position.The second long plate was also more difficult than usual.The surgeon did not use the awls as he did not believe the bone was hard enough to merit them.Upon removal of the inserter handle, it was noted that a piece of the peek implant had chipped off.The surgeon tugged on the plates to ensure they were secure without the chipped piece and the implant was left in place.There was a 10-minute delay without impact on the patient.This is report one of two for this event.
Additional Manufacturer Narrative
H6: additional investigation type code: 4109.Additional information in h6: component, investigation type, findings, and conclusions.Inspection.The device was not returned, however photos were provided which show that part of the device had fractured off and was removed.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¿s control.Potential root cause.A definitive root cause cannot be determined with the information provided.This event could possibly be attributed to the awl not being used during surgery.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.Reference report 3004788213-2023-00138.

• Brand Name: ROI-C LORDOTIC IMPLANT 14X17 H8
• Common Device Name: ROI-C TITANIUM-COATED IMPLANT SYSTEM
• 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: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 18222548
• Report Number: 3004788213-2023-00137
• Device Sequence Number: 6721385
• Product Code: OVE
• UDI-Device Identifier: 03662663016490
• UDI-Public: (01)03662663016490(17)270101(10)C88923
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151934
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/22/2024

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: MC1434P
• Device Lot Number: C88923
• 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: 11/28/2023
• Supplement Report FDA Received Date: 06/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic