MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORDOTIC IMPLANT 14X17 H6; LDR SPINE ROI-C CERVICAL CAGE SYSTEM

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial surgery, a roi-c plate bent and the cage was found to cracked.Another cage and plates were successfully implanted.There were no reported patient impacts.This is report one of two for this event.
Additional Manufacturer Narrative
Potential cause: this event could possibly be attributed to off-axis forces capable of overcoming the material properties applied during impaction.Additionally, per complaint description the patient has hard bone, which could contribute to this event.However, the definitive cause cannot be determined.Device evaluation: visual inspection revealed the cage has fractured.Dhr review and related actions: per dhr review, the part was 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.Reference report 3004788213-2020-00265.

• Brand Name: ROI-C LORDOTIC IMPLANT 14X17 H6
• Common Device Name: LDR SPINE ROI-C CERVICAL CAGE 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: 11222898
• Report Number: 3004788213-2020-00264
• Device Sequence Number: 4294476
• Product Code: OVE
• UDI-Device Identifier: 03662663016476
• UDI-Public: (01)03662663016476(17)240901(10)74302
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K150765
• 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
• Report Date (Section B): 01/25/2021

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 Model Number: N/A
• Device Catalogue Number: MC1432P
• Device Lot Number: 74302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/25/2021
• 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