MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 15X19 H5 US; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number	MB3595
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h6: investigation type, findings, and conclusions.A review of the dhr was conducted and found no indications of manufacturing issues.A visual inspection revealed that the inferior plate (mb121k lot 5713699) and the polyethylene insert have disassembled from the peek cartridge.The superior plate (mb080k lot 5695919) was still assembled to the cartridge.The item could be fully disassembled and reassembled using si-mobc-0001 with no difficulty.A functional inspection was performed with a mobi-c inserter (mb9001r) and found the implant was able to be inserted into the disc space of a spine model and the inserter released as expected.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for mobi-c implant 15 x 19 h5 (pn mb3595) for the failure of disassembly.The failure of disassembly could possibly be attributed to unintentional error during threading when the prosthesis was loaded into the implant holder.This device is used for treatment.
Event or Problem Description
It was reported that a mobi-c implant disassembled during implantation.The surgery was completed using a new implant, and there was no patient harm.
Event or Problem Description
It was reported that a mobi-c implant disassembled during implantation.The surgery was completed using a new implant, and there was no patient harm.
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X19 H5 US
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• 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: 23381380
• Report Number: 3004788213-2025-00060
• Device Sequence Number: 15714919
• Product Code: MJO
• UDI-Device Identifier: 03662663000185
• UDI-Public: (01)03662663000185(17)290601(10)5732421
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/15/2026

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: MB3595
• Device Lot Number: 5732421
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2024
• 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