MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 15X17 H5 US; MOBI-C CERVICAL DISC PROTHESIS

Catalog Number	MB3575
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Joint Laxity (4526)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a surgeon conducted a revision surgery to remove a mobi-c cervical disc due to structurally defective notches in the poly core that wore so they were 2x the normal size resulting in a 30% spondylolisthesis.The implant was replaced with a competitive disc.
Additional Manufacturer Narrative
Corrections in a1: gender, b7, d1, d4: catalog number and lot number, and g1.Additional information in a1 and d6b.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 surgeon conducted a revision surgery to remove a mobi-c cervical disc due to structurally defective notches in the poly core that wore so they were 2x the normal size resulting in a 30% spondylolisthesis.The implant was replaced with a competitive disc.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun (02)" no longer applies but cannot be removed.H6 additional investigation type: 4410.Corrections in h3.Additional information in d4: udi number and expiration date, h4, and h6: component, investigation type, findings, and conclusions.Inspection the articulating surface of the polyethylene insert showed machining marks, burnishing, pitting, deformation, discoloration, and multidirectional scratches.The superior and inferior endplates had evidence of damage consistent with impingement.The analysis showed minor deformation/gouging near the edges of the notches on the poly core, but no major deformation.The sales rep also provided a photo of the explanted poly core next to an unused poly core, which showed that the notches are still roughly the same size as they were initially.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.Potential 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.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 surgeon conducted a revision surgery to remove a mobi-c cervical disc due to structurally defective notches in the poly core that wore so they were 2x the normal size resulting in a 30% spondylolisthesis.The implant was replaced with a competitive disc.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X17 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: 19187931
• Report Number: 3004788213-2024-00036
• Device Sequence Number: 7403298
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: (01)03662663000154(17)200901(10)5253451
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 10/21/2024

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: 08/31/2020
• Device Catalogue Number: MB3575
• Device Lot Number: 5253451
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2024
• 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
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 08/30/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2015
• 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 Age: 46 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic