MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 13X17 H6 US; MOBI-C CERVICAL DISC PROTHESIS

Catalog Number	MB3376
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Paralysis (1997); Paresthesia (4421)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
A patient reported that a mobi-c implanted at c6/7 approximately 9 years prior had broken during their sleep; the mobile core fractured.The patient alleged intense pain for several weeks prior to emergency surgery to correct paralysis and a life threatening condition.The mobi-c was removed and the patient was converted to a fusion.
Event or Problem Description
A patient reported that a mobi-c implanted at c6/7 approximately 9 years prior had broken during their sleep; the mobile core fractured.The patient alleged intense pain for several weeks prior to emergency surgery to correct paralysis and a life threatening condition.The mobi-c was removed and the patient was converted to a fusion.
Additional Manufacturer Narrative
Corrections in b7, d1, d4: catalog number, e1, e2, e3, g1, and g2.Additional information in a5, a6, and b3.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
A patient reported that a mobi-c implanted at c6/7 approximately 9 years prior had broken during their sleep; the mobile core fractured.The patient alleged intense pain for several weeks prior to emergency surgery to correct paralysis and a life threatening condition.The mobi-c was removed and the patient was converted to a fusion.
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.H6: additional method code: 4110.Additional information in d4: udi number, and h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned, however a photo was provided which shows that the explanted device has a fractured poly core.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: 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.
Event or Problem Description
A patient reported that a mobi-c implanted at c6/7 approximately 9 years prior had broken during their sleep; the mobile core fractured.The patient alleged intense pain for several weeks prior to emergency surgery to correct paralysis and a life threatening condition.The mobi-c was removed and the patient was converted to a fusion.The patient visited a hospital er with the chief complaint of back and nerve pain.Patient claimed to work on a dairy and does a lot of manual labor.She felt an intense pain in upper back between shoulder blades three weeks prior and then felt pain in both arms since then.Earlier in the day, the patient went in for a steroid injection, but the injection was aborted because the provider said something felt wrong.Patient stated she was having trouble holding objects, decreased light touch sensation, and decreased temperature sensation in her right hand.Patient was discharged and driven to another hospital for an mri.After the mri was performed, the next day, the patient had lower extremity weakness.Toe movement was weak and she could not lift her leg off the bed on the right side.The patient stated she had hesitancy with initiation and some incontinence over the past several days.The mri found significant cord compression potentially due to the poly core extruding posteriorly from the disc replacement.A revision surgery was performed that day to remove the mobi-c and replace it with an acdf.The poly core was found fractured and was easily removed during the revision.
Additional Manufacturer Narrative
H6: additional patient codes: 2432, 1928, 2352, and 2415.Corrections in b5, b6, d6a, and h6: patient, device, and impact codes.Additional information in b7.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 13X17 H6 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: 19652398
• Report Number: 3004788213-2024-00053
• Device Sequence Number: 6848638
• Product Code: MJO
• UDI-Device Identifier: 03662663000109
• UDI-Public: (01)03662663000109
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MB3376
• 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; Not provided
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/19/2024; 12/11/2024; 03/17/2026
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White