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

Catalog Number	CMC1443P
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2020
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.Reference report 3004788213-2020-00150.Not returned to manufacturer.
Event or Problem Description
It was reported that the roi-c anchoring plate was stuck and could not advance further into the roi-c cage.A wider 15x5 cage and alternate anchoring plates were used as a replacements for surgery completion.There were no reported patient impacts.This is report 1 of 2 for this event.
Additional Manufacturer Narrative
Corrected information in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.This follow-up report is being submitted to relay additional information.The complaint is confirmed for one roi-c cage for the failure of the anchoring plate getting stuck/jammed in the cage during surgery.This device is used for treatment.No medical records were provided with the complaint.Inspection the devices show the anchoring plate stuck inside the cage.The complaint is confirmed.Dhr review the dhrs were reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimmer biomet¿s control.Potential root cause the failure is most likely to occur from hard (sclerotic) bone and not using the starter awl, skipping impactor #1 and using only impactor #2, or interference with an adjacent construct (typically a caspar pin).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 the roi-c anchoring plate was stuck and could not advance further into the roi-c cage.A wider 15x5 cage and alternate anchoring plates were used as a replacements for surgery completion.There were no reported patient impacts.This is report 1 of 2 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 MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 10613763
• Report Number: 3004788213-2020-00149
• Device Sequence Number: 2604803
• Product Code: OVE
• UDI-Device Identifier: 03662663023559
• UDI-Public: (01)03662663023559(17)241001(10)74229
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: 10/01/2024
• Device Catalogue Number: CMC1443P
• Device Lot Number: 74229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1