MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORDOTIC COATED IMPLANT 12 X14 H7; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the products were 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.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: this devices are used for treatment.Potential cause this event could possibly be attributed to off-axis forces capable of overcoming the material properties applied during impaction.With the given information, the definitive cause cannot be determined.Reference report 3004788213-2020-00253.
Event or Problem Description
It was reported that a plate was difficult to install into the mating cage and the cage was found to be broken after both pieces were removed intra-operatively.A new cage was installed, the awl was used to create the pathway for the plate, and a new plate was installed without issue.There were no reported patient impacts.This is report one of two for this event.

• Brand Name: ROI-C LORDOTIC COATED IMPLANT 12 X14 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, n/a 10300 ; FR 10300
• MDR Report Key: 11124109
• Report Number: 3004788213-2020-00252
• Device Sequence Number: 18993262
• Product Code: OVE
• UDI-Device Identifier: 03662663023559
• UDI-Public: (01)03662663023559(17)241201(10)75903
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2021

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: 12/01/2024
• Device Model Number: N/A
• Device Catalogue Number: CMC1443P
• Device Lot Number: 75903
• 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: 12/16/2020
• Initial Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1