MAUDE Adverse Event Report: LDR MEDICAL 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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2019
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.(b)(4).
Event or Problem Description
It was reported that during the procedure the second anchoring plate was almost fully inserted when it became jammed and would not advance further.The cage cracked and the plates and cage were removed.An alternate cage and plates of the same size were inserted to complete the case.There were no reported surgical delays or patient impacts.This is report two of two for this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Device evaluation: evaluation of available post-op images , revealed that cage was deformed (dented, stretched plastic, cracks) and anchoring plate had deformed.This is visible in images attached to the complaint file.Complaint could not be functionally tested because the products were not returned.Cracked cage complaint is confirmed.Dhr review and related actions per dhr review, the parts were likely conforming when it left zimmer biomet control.No actions required.This event is not related to any product holds.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 during the procedure the second anchoring plate was almost fully inserted when it became jammed and would not advance further.The cage cracked and the plates and cage were removed.An alternate cage and plates of the same size were inserted to complete the case.There were no reported surgical delays or patient impacts.This is report two of two for this event.
Additional Manufacturer Narrative
Corrections in d4: udi number, d9, and h3.Additional information in h6: component, impact, investigation type, and findings.Device evaluation: upon device return, visual inspection revealed the cage has fractured and has deformation damage.Device use these devices are 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 the procedure the second anchoring plate was almost fully inserted when it became jammed and would not advance further.The cage cracked and the plates and cage were removed.An alternate cage and plates of the same size were inserted to complete the case.There were no reported surgical delays or patient impacts.This is report two of two for this event.

• Brand Name: IMPLANT ROI-C 12X14 H6
• Common Device Name: LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
• Manufacturer (Section D): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: florence maily ; quartier europe de l'ouest; 5, rue de berlin; sainte-savine, na ; 33382803
• MDR Report Key: 9387284
• Report Number: 3004788213-2019-00329
• Device Sequence Number: 16696210
• Product Code: ODP
• UDI-Device Identifier: 03662663016285
• UDI-Public: (01)03662663016285(17)231001(10)68506
• 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: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2022

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: 10/10/2023
• Device Catalogue Number: MC1342P
• Device Lot Number: 68506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 10/31/2019; 04/26/2022
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 10/22/2020; 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown