MAUDE Adverse Event Report: LDR MEDICAL ROI-C COATED IMPLANT 14X15.5 H6; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	CMC1322P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 phone number: (b)(6).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.
Event or Problem Description
It was reported that the second plate of an roi-c construct could not be installed within the spacer intra-operatively.During installation of the second construct at the adjacent level, a piece of the anterior portion of the spacer broke off and was wedged in the channel between the spacer and the plate; the piece could not be recovered.There was a delay of 30 minutes to the procedure, but there have been no reported patient impacts.This is report two of two for this event.
Additional Manufacturer Narrative
If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference report (b)(4).
Event or Problem Description
It was reported that the second plate of an roi-c construct could not be installed within the spacer intra-operatively.During installation of the second construct at the adjacent level, a piece of the anterior portion of the spacer broke off and was wedged in the channel between the spacer and the plate; the piece could not be recovered.There was a delay of 30 minutes to the procedure, but there have been no reported patient impacts.This is report two of two for this event.
Event or Problem Description
It was reported that the second plate of an roi-c construct could not be installed within the spacer intra-operatively.During installation of the second construct at the adjacent level, a piece of the anterior portion of the spacer broke off and was wedged in the channel between the spacer and the plate; the piece could not be recovered.There was a delay of 30 minutes to the procedure, but there have been no reported patient impacts.This is report two of two for this event.
Additional Manufacturer Narrative
H6: additional method code: 4109.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the product was not returned so an evaluation was unable to be performed, however photos were provided.The provided photos show that a inferior plate was not installed but do not clearly show that the cage was fractured so the complaint remains unrefuted.Root cause: a definitive root cause cannot be determined with the information provided.The second anchoring plate was unable to advance through the cage because the cage had fractured and a piece was jammed in the anchoring plate pathway.The cage fracture could be related to difficulty implanting the first anchoring plate.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.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.

• Brand Name: ROI-C COATED IMPLANT 14X15.5 H6
• Common Device Name: ROI-C TITANIUM-COATED IMPLANT SYSTEM
• Manufacturer (Section D): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 18456320
• Report Number: 3004788213-2024-00145
• Device Sequence Number: 16922911
• Product Code: OVE
• UDI-Device Identifier: 03662663023184
• UDI-Public: (01)03662663023184(17)270401(10)C91032
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151934
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2024

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 Catalogue Number: CMC1322P
• Device Lot Number: C91032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/26/2024; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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: Male
• Patient Ethnicity: Non Hispanic