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

Catalog Number	MB3355
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to remove two mobi-c implants and convert to a fusion.The patient's radicular symptoms returned and the revising surgeon felt the implants were improperly sized and implanted, and the levels were not fully decompressed.The mobi-c devices were installed approximately four years ago.This is report one of two for this event.
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 revision surgery was performed to remove two mobi-c implants and convert to a fusion.The patient's radicular symptoms returned and the revising surgeon felt the implants were improperly sized and implanted, and the levels were not fully decompressed.The mobi-c devices were installed approximately four years ago.This is report one of two for this event.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun (02)" no longer applies but cannot be removed.H6 additional investigation type code: 4110.Corrections in h3.Additional information in d4: expiration date and udi number, h4, and h6: component, investigation type, findings, and conclusions.Inspection: all four endplates showed evidence of iatrogenic damage.The polyethylene inserts showed machining marks, burnishing, pitting, and multidirectional scratches.Both polyethylene inserts had evidence of cutout deformation.Stage iii analysis was conducted to assess the condition of the polyethylene inserts.Stage iii analysis found a low (oi <1) and moderate to severe oxidation (1 = oi = 3) of the inserts at the tab and dome regions.The mechanical properties were consistent with the level of oxidation.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 zimvie¿s control.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.Reference report 3004788213-2023-00076.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 13X15 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROSTHESIS
• 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: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17715410
• Report Number: 3004788213-2023-00075
• Device Sequence Number: 11310015
• Product Code: MJO
• UDI-Device Identifier: 03662663000000
• UDI-Public: (01)03662663000000(17)240201(10)5335338
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2019
• 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
• Report Date (Section B): 07/07/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: MB3355
• Device Lot Number: 5335338
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/23/2023
• 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: 09/08/2023
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic