MAUDE Adverse Event Report: LDR MEDICAL ROI-C LONG ANCHORING PLATE; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1006T
Medical Device Problem Codes	Difficult to Insert (1316); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2020
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.(b)(4).
Event or Problem Description
It was reported that during the procedure the anchoring plate was difficult to insert and the cage broke.The plate and cage were removed and replaced with alternates to complete the case with no reported patient harm.This is report two of two for this event.
Additional Manufacturer Narrative
Roi-c long anchoring plate, part: mc1006t, lot: 737178, qty: 1.The complaint is unrefuted for one (1) out of one (1) roi-c anchoring plate (part number mc1006t) for the reported failure of deformation during plate insertion.The severity of this event is 0 ((b)(4)).The device was likely conforming when it left zimmer biomet's control.No action is recommended.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.Device use and compatibility: this devices are used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.Corrective/preventive action: no corrective or preventive actions are recommended at this time.
Event or Problem Description
It was reported that during the procedure the anchoring plate was difficult to insert and the cage broke.The plate and cage were removed and replaced with alternates to complete the case with no reported patient harm.This is report two of two for this event.

• Brand Name: ROI-C LONG ANCHORING PLATE
• Common Device Name: ROI-C TITANIUM-COATED IMPLANT SYSTEM
• Manufacturer (Section D): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 9790139
• Report Number: 3004788213-2020-00017
• Device Sequence Number: 14025509
• Product Code: OVE
• UDI-Device Identifier: 03662663016988
• UDI-Public: (01)03662663016988(17)230401(10)737178
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K151934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 04/01/2023
• Device Catalogue Number: MC1006T
• Device Lot Number: 737178
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1