MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 13X15 H5 US; MOBI-C CERVICAL DISC PROTHESIS

Catalog Number	MB3355
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 after a mobi-c implant was implanted, imaging showed that the inferior plate was misaligned.It is currently unknown whether the implant was revised or if it remains implanted.There were no reported patient impacts.
Event or Problem Description
It was reported that after a mobi-c implant was implanted, imaging showed that the inferior plate was misaligned.It is currently unknown whether the implant was revised or if it remains implanted.There were no reported patient impacts.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned and no photos were provided, so an evaluation is unable to be performed.Root cause: a definitive root cause cannot be determined with the information provided.The retention feature failure could possibly be attributed to mishandling during attachment to the inserter.The misalignment after implantation could possibly be attributed to unknown patient or surgical factors.Dhr review: the lot number was not reported and the device was not returned, therefore a dhr review is unable to be performed.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: MOBI-C IMPLANT "M" STANDARD 13X15 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROTHESIS
• 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: 20579388
• Report Number: 3004788213-2024-00084
• Device Sequence Number: 20859587
• Product Code: MJO
• UDI-Device Identifier: 03662663000000
• UDI-Public: (01)03662663000000
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: MB3355
• 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: 10/31/2024
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Ethnicity: Non Hispanic