MAUDE Adverse Event Report: LDR MÉDICAL ROI-C IMPLANT 12X14 H6MM; LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

Catalog Number	MC1342P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2020
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
It was reported that an roi-c cage fractured during surgery while the mating plate was being installed.The cage was removed, and replaced with an alternative cage to complete the procedure.There were no patient impacts reported.
Event or Problem Description
It was reported that an roi-c cage fractured during surgery while the mating plate was being installed.The cage was removed and replaced with an alternative cage to complete the procedure.There were no patient impacts reported.This is report one of two for this event.
Additional Manufacturer Narrative
Corrected information in b5, d10 and h3.Additional information in h6: method, results, and conclusions.This follow-up report is being submitted to relay additional information.The complaint is confirmed for one cage for the failure of cage cracking during plate impaction.The cause of the damage cannot be determined at this time since there is no information available regarding how the implants were being used or handled at the time of the damage.Per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.The device is used for treatment.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 (b)(4).

• Brand Name: ROI-C IMPLANT 12X14 H6MM
• 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 10300 ; FR 10300
• MDR Report Key: 10864589
• Report Number: 3004788213-2020-00194
• Device Sequence Number: 14093040
• Product Code: ODP
• UDI-Device Identifier: 03662663016285
• UDI-Public: (01)03662663016285(17)240101(10)69837
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: 01/01/2024
• Device Catalogue Number: MC1342P
• Device Lot Number: 69837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 71