MAUDE Adverse Event Report: LDR MÉDICAL ROI-C IMPLANT 12X15.5 H6; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1352P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
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 3004788213-2020-00173.
Event or Problem Description
It was reported that during a procedure, an roi-c fractured during plate installation; the plate would not advance without several very hard hits with a mallet.The cage and plate were removed from the wound and replaced with an alternative cage and plate to complete the procedure.It was also reported that x-rays were not taken prior to plate installation to ensure proper cage placement and distance from the retraction pins.There were no reported patient impacts associated with this event.This is report one of two for this event.
Event or Problem Description
It was reported that during a procedure, an roi-c fractured during plate installation; the pate would not advance without several very hard hits with a mallet.The cage and plate were removed from the wound and replaced with an alternative cage and plate to complete the procedure.It was also reported that x-rays were not taken prior to plate installation to ensure proper cage placement and distance from the retraction pins.There were no reported patient impacts associated with this event.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.Information added to d10, h3, and h6: method, results, and conclusions.The complaint is confirmed for one (1) of one (1) roi-c cage (pn: mc1352p) for the failure of cracked.Medical records were not provided for review.Device evaluation: visual inspection of the cage shows that it has fractured.The complaint is confirmed.Potential cause root cause was unable to be determined.Dhr review and related actions per dhr review, the parts were likely conforming when they left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: ROI-C IMPLANT 12X15.5 H6
• 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: 10759709
• Report Number: 3004788213-2020-00172
• Device Sequence Number: 11602652
• Product Code: OVE
• UDI-Device Identifier: 03662663016353
• UDI-Public: (01)03662663016353(17)240901(10)73688
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/04/2020

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: 09/01/2024
• Device Catalogue Number: MC1352P
• Device Lot Number: 73688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 75