MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT ROI-C 12X14 H6; LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

Catalog Number	MC1342P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
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.Reference report (b)(4).
Event or Problem Description
It was reported an roi-c cage and plate were broken during installation within surgery.The removal of these implants caused a delay of 30 minutes but the patient is in good condition after surgery and has been discharged from the hospital.This is report two of two for this event.
Event or Problem Description
It was reported an roi-c cage and plate were broken during installation within surgery.The removal of these implants caused a delay of 30 minutes but the patient is in good condition after surgery and has been discharged from the hospital.This is report two of two for this event.
Additional Manufacturer Narrative
Inspection: the products were returned and visual inspection found that the plate has some gouges/deformation damage and the cage is deformed and fractured.Dhr review: the dhrs were reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimvie¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces applied during use.The damage to the returned parts could have also occurred during the removal of the parts.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.

• Brand Name: IMPLANT ROI-C 12X14 H6
• Common Device Name: LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 15342181
• Report Number: 3004788213-2022-00068
• Device Sequence Number: 14596237
• Product Code: ODP
• UDI-Device Identifier: 03662663016285
• UDI-Public: (01)03662663016285(17)241201(10)77363
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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 Expiration Date: 12/01/2024
• Device Catalogue Number: MC1342P
• Device Lot Number: 77363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2019
• 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 Sex: Unknown