MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORDOTIC IMPLANT 14X15,5 H7; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1423P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: the product was not returned and no photos, intra-op/post-op images, or surgical notes were provided, so an evaluation is unable to be performed.The complaint is non-verifiable for the reported failure.Complaint history: there were zero (0) other complaints for similar events (revision surgery) 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.Device use and compatibility: this device is used for treatment.Reported event is not related to a combination of product lines; therefore, a compatibility review is not applicable.Potential cause: this event could possibly be attributed implant not compatible with patient which cased revision surgery.However, with the available information and product not returned, the event cannot be attributed any cause.Corrective/preventive action: no corrective or preventive actions are recommended at this time.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 following a surgery where two roi-c constructs were implanted, the patient suffered from neurological deficits but was not paralyzed.A revision surgery was performed the next day to remove one of the constructs and replace it with a narrower size of the same type.No further information is available.

• Brand Name: ROI-C LORDOTIC IMPLANT 14X15,5 H7
• Common Device Name: ROI-C TITANIUM-COATED IMPLANT SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 10750746
• Report Number: 3004788213-2020-00196
• Device Sequence Number: 3125523
• Product Code: OVE
• UDI-Device Identifier: 03662663016421
• UDI-Public: (01)03662663016421(17)220301(10)56542
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K151934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: 03/01/2022
• Device Catalogue Number: MC1423P
• Device Lot Number: 56542
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1