MAUDE Adverse Event Report: LDR MÉDICAL ROI-C COATED IMPLANT 14X15,5 H6; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	CMC1322P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
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 3004788213-2021-00073.
Event or Problem Description
It was reported that during plate insertion, the cage and plate were damaged intra-operatively.A new cage and plate were used to complete the procedure without patient impacts.This is report one of two for this event.
Additional Manufacturer Narrative
Device evaluation: product was not returned and photos were not provided, so device evaluation could not be performed.Potential cause: root cause was unable to be determined.It is possible that the patient had hard bone, making the impaction of the plate so difficult that the plate bent and the cage fractured.Dhr review: per dhr reviews, the parts were likely conforming when they left zimmer biomet control.Device use: 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.
Event or Problem Description
It was reported that during plate insertion, the cage and plate were damaged intra-operatively.A new cage and plate were used to complete the procedure without patient impacts.This is report one of two for this event.

• Brand Name: ROI-C COATED IMPLANT 14X15,5 H6
• Common Device Name: ROI-C TITANIUM-COATED IMPLANT 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: 12144797
• Report Number: 3004788213-2021-00072
• Device Sequence Number: 3820940
• Product Code: OVE
• UDI-Device Identifier: 03662663023184
• UDI-Public: (01)03662663023184(17)241001(10)73705
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: 10/01/2024
• Device Catalogue Number: CMC1322P
• Device Lot Number: 73705
• Was Device Available for Evaluation?: No
• 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: 06/17/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 98 KG