MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 15X15 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3555
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
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 during a surgery, a mobi-c implant disassembled in the disc space and was difficult to remove from the inserter.The implant was replaced and the surgery was completed with only a 5-7 minute delay and no patient impact.
Additional Manufacturer Narrative
The device was not returned so an evaluation is unable to be performed, and the failure modes could not be confirmed from the photo provided.Root cause: a definitive root cause cannot be determined, but disassembly of the implant could be caused by off-axis forces applied to the device while within the disc space, causing the implant to prematurely release from the inserter.Difficulty releasing the implant from the inserter could be caused by turning the unlocking key the incorrect direction.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s 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.
Event or Problem Description
It was reported that during a surgery, a mobi-c implant disassembled in the disc space and was difficult to remove from the inserter.The implant was replaced and the surgery was completed with only a 5-7 minute delay and no patient impact.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X15 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROSTHESIS
• 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: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 20904961
• Report Number: 3004788213-2024-00088
• Device Sequence Number: 3969041
• Product Code: MJO
• UDI-Device Identifier: 03662663000062
• UDI-Public: (01)03662663000062(17)270601(10)5416026
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: MB3555
• Device Lot Number: 5416026
• 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
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• 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 Age: 25 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic