MAUDE Adverse Event Report: LDR MÉDICAL ROI-C IMPLANT 14X17 H6MM; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1332P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
The roi-c peek fractured during the cage insertion process.A new implant was used to complete the operation.
Event or Problem Description
The roi-c peek fractured during the cage insertion process.A new implant was used to complete the operation.
Additional Manufacturer Narrative
Corrected information in d9 and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.This follow-up report is being submitted to relay additional information.Medical records were not provided for review.Device evaluation: per visual inspection, the cage has fractured.Potential cause: root cause was unable to be determined.This event could possibly be attributed to hard bone, plates being off-angle during impaction or other patient or operational conditions.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device use: this device is used for treatment.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 14X17 H6MM
• 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: 11201582
• Report Number: 3004788213-2020-00262
• Device Sequence Number: 11320707
• Product Code: OVE
• UDI-Device Identifier: 03662663016216
• UDI-Public: (01)03662663016216(17)240901(10)74328
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 09/01/2024
• Device Catalogue Number: MC1332P
• Device Lot Number: 74328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 72