MAUDE Adverse Event Report: LDR MEDICAL ROI-C SHORT ANCHORING PLATE; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1005T
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
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 a revision surgery was performed to address an anchor plate the fractured post-operatively.The patient was converted to a fusion and is doing well.The plate remains implanted in the patient.
Additional Manufacturer Narrative
Corrected information in b6.Additional information h6: component, investigation type, findings, and conclusions.Additional method code in h6: historical data analysis: 4109.Device evaluation: product was not returned, however x-rays were provided.The plate is seen to have fractured.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown patient, operational or traumatic factors.Dhr review: dhr review was unable to be completed as lot information is not known.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.
Event or Problem Description
It was reported a revision surgery was performed to address an anchor plate the fractured post-operatively.The patient was converted to a fusion and is doing well.The plate remains implanted in the patient.
Additional Manufacturer Narrative
Corrected information in d4: lot number.Additional information a2, a3, d4: expiration date and udi number, h4, and h6: investigation type.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 zimvie¿s control.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported a revision surgery was performed to address an anchor plate the fractured post-operatively.The patient was converted to a fusion and is doing well.The plate remains implanted in the patient.

• Brand Name: ROI-C SHORT ANCHORING PLATE
• 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: 17311904
• Report Number: 3004788213-2023-00065
• Device Sequence Number: 7185535
• Product Code: OVE
• UDI-Device Identifier: 03662663016971
• UDI-Public: (01)03662663016971(17)270201(10)864551
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K151934
• 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): 11/09/2023

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: Lay User/Patient
• Device Catalogue Number: MC1005T
• Device Lot Number: 864551
• Was Device Available for Evaluation?: No
• 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: 07/12/2023
• Supplement Report FDA Received Date: 10/06/2023; 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic