MAUDE Adverse Event Report: LDR MÉDICAL ROI-C IMPLANT 12X15.5 H5MM; LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

Catalog Number	MC1351P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
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 3004788213-2021-00142.
Event or Problem Description
It was reported that the second roi-c plate was difficult to install intraoperatively because it kept hitting the first plate, which caused the cage the break.The cage and plates were removed and replaced with competitive products to complete the procedure.There was a surgical delay without reported patient impacts.This is report two of two for this event.
Additional Manufacturer Narrative
Inspection: the products could not be evaluated since they were not returned and there were no photos provided.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: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces applied during use.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that the second roi-c plate was difficult to install intraoperatively because it kept hitting the first plate, which caused the cage the break.The cage and plates were removed and replaced with competitive products to complete the procedure.There was a surgical delay without reported patient impacts.This is report two of two for this event.

• Brand Name: ROI-C IMPLANT 12X15.5 H5MM
• Common Device Name: LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 12760814
• Report Number: 3004788213-2021-00143
• Device Sequence Number: 4151976
• Product Code: ODP
• UDI-Device Identifier: 03662663016346
• UDI-Public: (01)03662663016346(17)220601(10)24683R268
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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: 06/01/2022
• Device Catalogue Number: MC1351P
• Device Lot Number: 24683R268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown