MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT ROI-C 14X17 H5; LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
It was reported that a cage broke while being driven in.The anterior part of the cage was stuck to the implant holder and the rest of the cage was firmly anchored in the patient.The part that was anchored in the patient was explanted without any problems and the a new cage was implanted.The cage was implanted according to surgical procedure.
Additional Manufacturer Narrative
Correction: h3 additional information: h6: component codes, type of investigations, findings, and conclusions.Device evaluation visual inspection of the device reveals that the implant was fractured.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device use: this device is used for treatment.The reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.Potential cause: the fracture 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.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported that a cage broke while being driven in.The anterior part of the cage was stuck to the implant holder and the rest of the cage was firmly anchored in the patient.The part that was anchored in the patient was explanted without any problems and the a new cage was implanted.The cage was implanted according to surgical procedure.

• Brand Name: IMPLANT ROI-C 14X17 H5
• 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, n/a 10300 ; FR 10300
• MDR Report Key: 12042104
• Report Number: 3004788213-2021-00065
• Device Sequence Number: 17143837
• Product Code: ODP
• UDI-Device Identifier: 03662663016209
• UDI-Public: (01)03662663016209(17)250301(10)78194
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091088
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: 03/01/2025
• Device Model Number: N/A
• Device Catalogue Number: MC1331P
• Device Lot Number: 78194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1