MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORDOTIC IMPLANT 14X15.5 H7; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1423P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
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.
Event or Problem Description
Reported that once the implant was fully inserted, the top half fractured off after inserting the second plate.The surgeon removed the implant and replaced it with a new implant & plates to complete the case without impact to the patient.
Event or Problem Description
It was reported that once the implant was fully inserted, the top half fractured off after inserting the second plate.The surgeon removed the implant and replaced it with a new implant & plates to complete the case without impact to the patient.
Additional Manufacturer Narrative
Inspection: the product was not returned and no photos were provided, so an evaluation is unable to be performed.Potential root cause: the fracture often occurs due to the plate applying force on the strut that is on the anterior side of the groove.The force can come from the plate entering hard bone and bending from the resistance, from the cage moving posteriorly after the plate has been partially or totally inserted, or from the first plate not being fully inserted or some other obstruction in the groove.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 zimmer biomet¿s control.Device usage: this device is used for treatment.

• Brand Name: ROI-C LORDOTIC IMPLANT 14X15.5 H7
• 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
• MDR Report Key: 12229321
• Report Number: 3004788213-2021-00079
• Device Sequence Number: 1494532
• Product Code: OVE
• UDI-Device Identifier: 03662663016421
• UDI-Public: (01)03662663016421(17)240901(10)74296
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 09/01/2024
• Device Catalogue Number: MC1423P
• Device Lot Number: 74296
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1