MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT ROI-C 14X15,5 H5; LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

Catalog Number	MC1321P
Medical Device Problem Codes	Failure to Osseointegrate (1863); Unintended Movement (3026)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
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 3004788213-2020-00192.
Event or Problem Description
It was reported that a pseudoarthrosis and micromovement of an roi-c construct were detected at a three-year follow up review.At the time of construct placement, a disk replacement device was also used, apparently at an adjacent level.There are no current plans for a revision of the roi-c construct.This is report one of two for this event.
Event or Problem Description
It was reported that a pseudoarthrosis and micromovement of an roi-c construct were detected at a three-year follow up review.At the time of construct placement, a disk replacement device was also used, apparently at an adjacent level.There are no current plans for a revision of the roi_c construct.This is report one of two for this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and initially corrected information.Device evaluation: the products remains implanted.There were also no medical images or operation notes provided for evaluation.With the available information the complaint is unrefuted for failure of non-union and micromovement of the cage.Complaint history: for pn# mc1321p ln# 55723 there were zero (0) other complaints for similar events (non-union and micromovement of the cage.) related to the same part number in the 12 months leading up to the notification date through to the present.0(zero) additional search results for the lot and item search.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.Potential cause: as the cage and plate remains implanted, with the given information, the definitive cause cannot be determined.This event could possibly be attributed to unintended motion of patient, post operation a follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: IMPLANT ROI-C 14X15,5 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, na 10300 ; FR 10300
• MDR Report Key: 10760438
• Report Number: 3004788213-2020-00191
• Device Sequence Number: 3358743
• Product Code: ODP
• UDI-Device Identifier: 03662663016131
• UDI-Public: (01)03662663016131(17)220201(10)55723
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K091088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: MC1321P
• Device Lot Number: 55723
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other