MAUDE Adverse Event Report: LDR MEDICAL ROI-C IMPLANT 14MM X 14MM H7MM; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1313P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2023
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.
Event or Problem Description
It was reported that a surgeon had multiple roi-c cages that fractured or cracked intra-operatively.Two cages fractured at level c7/t1 after inserting the anchoring plates.They were each removed and replaced with a new cage.The third cage cracked and the surgeon elected to leave it in place.The surgeon proceeded to the c6/7 level and installed the first cage, but it was found to have fractured after the first anchoring plate was installed.The cage was again removed and replaced with a new cage and the surgeon elected not to install the anchoring plates at that level.There was a delay of three hours to the procedure without reported patient impacts.This is report three of four for this event.
Event or Problem Description
It was reported that a surgeon had multiple roi-c cages that fractured or cracked intra-operatively.Two cages fractured at level c7/t1 after inserting the anchoring plates.They were each removed and replaced with a new cage.The third cage cracked and the surgeon elected to leave it in place.The surgeon proceeded to the c6/7 level and installed the first cage, but it was found to have fractured after the first anchoring plate was installed.The cage was again removed and replaced with a new cage and the surgeon elected not to install the anchoring plates at that level.There was a delay of three hours to the procedure without reported patient impacts.This is report three of four for this event.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the cage is fractured.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.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.Reference reports 3004788213-2023-00083 through 3004788213-2023-00086.

• Brand Name: ROI-C IMPLANT 14MM X 14MM H7MM
• 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: 17967553
• Report Number: 3004788213-2023-00085
• Device Sequence Number: 7754782
• Product Code: OVE
• UDI-Device Identifier: 03662663016087
• UDI-Public: (01)03662663016087(17)241101(10)75947
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K151934
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,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 Expiration Date: 10/31/2024
• Device Catalogue Number: MC1313P
• Device Lot Number: 75947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2020
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic