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

Catalog Number	MC1342P
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2020
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.Reference report 3004788213-2020-00187.
Event or Problem Description
It was reported that an roi-c plate became jammed inside the cage during attempted assembly intra-operatively.In order to remove the plate, the surgeon broke the cage.Both pieces were successfully removed from the patient and replaced without reported patient impacts.This is report one of two for this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to correct initially reported information.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 an roi-c plate became jammed inside the cage during attempted assembly intra-operatively.In order to remove the plate, the surgeon broke the cage.Both pieces were successfully removed from the patient and replaced without reported patient impacts.This is report one of two for this event.
Additional Manufacturer Narrative
Added information to d3: email address, d8, h6: component codes, type of investigation, investigation findings, investigation conclusions.Corrected information in d9, h3.This follow-up report is being submitted to relay additional information and initially corrected information.Summary: the complaint is confirmed for one (1) of one (1) roi-c cage (pn mc1342p) for the failure of damage during insertion.Medical records were not provided for review.Device evaluation: the product was not returned for device evaluation, but the plates and cages are seen to be damaged in the returned photos.Potential cause: root cause was unable to be determined.This event could possibly be attributed to patient conditions or due to surgical conditions not described in the complaint.Dhr review and related actions 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.Device use: this device is used for treatment.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 an roi-c plate became jammed inside the cage during attempted assembly intra-operatively.In order to remove the plate, the surgeon broke the cage.Both pieces were successfully removed from the patient and replaced without reported patient impacts.This is report one of two for this event.

• 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, na 10300 ; FR 10300
• MDR Report Key: 10727392
• Report Number: 3004788213-2020-00186
• Device Sequence Number: 11625636
• Product Code: ODP
• UDI-Device Identifier: 03662663016285
• UDI-Public: (01)03662663016285(17)240701(10)73152
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2021

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: 07/01/2024
• Device Catalogue Number: MC1342P
• Device Lot Number: 73152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/27/2020
• Supplement Date Received by Manufacturer: 10/16/2020; 03/26/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/10/2020; 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR