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

Catalog Number	MB3555
Medical Device Problem Codes	Fracture (1260); Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Type of Reportable Event	Serious Injury
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 revision surgery was performed for a mobi-c construct that was causing pain and numbness in the patient.During the revision surgery it was discovered that the left anterior corner of the mobile core had fractured, allowing the core to shift alignment and collapsing the posterior portion of the c3-c4 construct.The mobi-c was removed and replaced with an acdf.
Additional Manufacturer Narrative
Corrections in d9, g1, and h3.Additional information in h6: component, investigation type, findings, and conclusions.Inspection the device evaluation found the articulating surface of the polyethylene insert showed iatrogenic damage, pitting and multidirectional scratches consistent with minimal wear.There were also areas of abrasion and deformation on the polyethylene insert.The superior and inferior endplates and the polyethylene insert had evidence of damage consistent with impingement.The polyethylene insert was fractured.Additionally, x-ray images were provided that showed the mobi-c plates are misaligned and fish mouthed.Dhr review the part/lot number reported does not match any known records (see attached correspondence), therefore a dhr is unable to be located for review.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown surgical or patient factors.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported that a revision surgery was performed for a mobi-c construct that was causing pain and numbness in the patient.During the revision surgery it was discovered that the left anterior corner of the mobile core had fractured, allowing the core to shift alignment and collapsing the posterior portion of the c3-c4 construct.The mobi-c was removed and replaced with an acdf.
Event or Problem Description
It was reported that a revision surgery was performed for a mobi-c construct that was causing pain and numbness in the patient.During the revision surgery it was discovered that the left anterior corner of the mobile core had fractured, allowing the core to shift alignment and collapsing the posterior portion of the c3-c4 construct.The mobi-c was removed and replaced with an acdf.
Additional Manufacturer Narrative
Device evaluation: the device was sent to exponent for evaluation.Their investigation found the articulating surface of the polyethylene insert showed iatrogenic damage, pitting and multidirectional scratches consistent with minimal wear.There were also areas of abrasion and deformation on the polyethylene insert.The superior and inferior endplates and the polyethylene insert had evidence of damage consistent with impingement.The polyethylene insert was fractured.Additionally, x-ray images were provided that showed the mobi-c plates are misaligned and fish mouthed.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown surgical or patient factors.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¿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 a revision surgery was performed for a mobi-c construct that was causing pain and numbness in the patient.During the revision surgery it was discovered that the left anterior corner of the mobile core had fractured, allowing the core to shift alignment and collapsing the posterior portion of the c3-c4 construct.The mobi-c was removed and replaced with an acdf.
Additional Manufacturer Narrative
H6: additional method code: 4110.Corrections in h6: investigation type, findings, and conclusions.Device evaluation: the device was sent to exponent for evaluation.Their investigation found the articulating surface of the polyethylene insert showed iatrogenic damage, pitting and multidirectional scratches consistent with minimal wear.There were also areas of abrasion and deformation on the polyethylene insert.The superior and inferior endplates and the polyethylene insert had evidence of damage consistent with impingement.The polyethylene insert was fractured.Additionally, x-ray images were provided that show the upper plate has loosened from the bone, as evidenced by the darker area between the plate and the bone.The lower plate is misaligned in the disc space, as evidenced by comparing it to the orientation of the acdf plate.The implant has also fish mouthed and is too large, as evidenced by how the plates protrude from the disc space on the anterior and posterior sides.Root cause: the imaging indicates that the implant has an a/p length that is too long, as indicated by the implant plates protruding too far anteriorly and posteriorly.An implant that is too large could prevent the implant from properly seating, leading to loosening and misalignment of the plates.Review of the imaging also shows that the implant plates are fish mouthed in the disc space.When coupled with the impingement marks on the explanted device, these point towards the pll not being released, as suggested by the device labeling.In both of these instances, it is probable that incorrect size selection and failure to follow the labeling contributed to this event.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¿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.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X15 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: 18364910
• Report Number: 3004788213-2023-00143
• Device Sequence Number: 18169831
• Product Code: MJO
• UDI-Device Identifier: 03662663000062
• UDI-Public: (01)03662663000062(17)231001(10)5324604
• 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: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/19/2025

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 Expiration Date: 09/30/2023
• Device Catalogue Number: MB3555
• Device Lot Number: 5324604
• Was Device Available for Evaluation?: Yes
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 07/27/2024; 11/21/2024; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic