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

Catalog Number	MB3595
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 additional investigation type code: 4111.Additional information in: h6: component, investigation type, findings, and conclusions.Inspection: the device was not returned and no photos were provided, so an evaluation is unable to be performed.Medical documents were provided that confirm the return of the patient's symptoms and a post-op infection.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.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.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
A patient via voluntary medwatch mw5162232 reported having multiple clinical symptoms after having a mobi-c implant installed.Symptoms include: unable to lift right arm immediately post-op, weakness when lifting arm at time of discharge from hospital, severe infection days after surgery which was treated with antibiotics, hospitalization for an acute psychiatric event about one-two months post-op, lost full use of right and left arm, then a revision surgery was performed approximately one year post-op.No details were provided for the reason for or actions taken during the revision surgery.Approximately two years post-revision, the patient was diagnosed with als but her condition has remained stable and there has not been much further weakness.The patient recently fell which prompted a lumbar puncture.The patient is exploring having a metal sensitivity or an anti-inflammatory response to see if that caused the condition.Imaging shows fatty muscle infiltration: "possibly representing post infectious or inflammatory process" edema or paraspinal muscles and leptomeningeal enhancement.No discrete mass or lesion.Radiology has mixed impressions through the years, but nothing defective with placement or fixation of device.Additional information: testing approximately 1 year post-operative indicated that there was no hardware failure at c4/5 or c5/6 and the prosthesis at c4/5 was somewhat rotated.Additionally, active denervation was found at the c5/6 level.This is report two of two for this event.
Additional Manufacturer Narrative
D4 udi number: the udi number is unknown since the part and lot numbers are unknown.H6 additional clinical codes: 1967, 1994, 1997, 2551, 4577, and 4595.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.The patient reported this event on mw5162232.Reference report 3004788213-2025-00001.
Event or Problem Description
A patient via voluntary medwatch mw5162232 reported having multiple clinical symptoms after having a mobi-c implant installed.Symptoms include: unable to lift right arm immediately post-op, weakness when lifting arm at time of discharge from hospital, severe infection days after surgery which was treated with antibiotics, hospitalization for an acute psychiatric event about one-two months post-op, lost full use of right and left arm, then a revision surgery was performed approximately one year post-op.No details were provided for the reason for or actions taken during the revision surgery.Approximately two years post-revision, the patient was diagnosed with als but her condition has remained stable and there has not been much further weakness.The patient recently fell which prompted a lumbar puncture.The patient is exploring having a metal sensitivity or an anti-inflammatory response to see if that caused the condition.Imaging shows fatty muscle infiltration: "possibly representing post infectious or inflammatory process" edema or paraspinal muscles and leptomeningeal enhancement.No discrete mass or lesion.Radiology has mixed impressions through the years, but nothing defective with placement or fixation of device.This is report two of two for this event.
Event or Problem Description
A patient via voluntary medwatch mw5162232 reported having multiple clinical symptoms after having a mobi-c implant installed.Symptoms include: unable to lift right arm immediately post-op, weakness when lifting arm at time of discharge from hospital, severe infection days after surgery which was treated with antibiotics, hospitalization for an acute psychiatric event about one-two months post-op, lost full use of right and left arm, then a revision surgery was performed approximately one year post-op.No details were provided for the reason for or actions taken during the revision surgery.Approximately two years post-revision, the patient was diagnosed with als but her condition has remained stable and there has not been much further weakness.The patient recently fell which prompted a lumbar puncture.The patient is exploring having a metal sensitivity or an anti-inflammatory response to see if that caused the condition.Imaging shows fatty muscle infiltration: "possibly representing post infectious or inflammatory process" edema or paraspinal muscles and leptomeningeal enhancement.No discrete mass or lesion.Radiology has mixed impressions through the years, but nothing defective with placement or fixation of device.Additional information: testing approximately 1 year post-operative indicated that there was no hardware failure at c4/5 or c5/6 and the prosthesis at c4/5 was somewhat rotated.Additionally, active denervation was found at the c5/6 level.This is report two of two for this event.
Additional Manufacturer Narrative
H6 additional clinical codes: 1967, 1994, 1997, 2551, 4577, 4595, and 4581.Code 4581 appropriate term: denervation.Additional information in: a2: dob, a3, d6a, d6b, h4 and h6: clinical code.Corrected information in: b5; b6; b7; d1; and d4: catalog number, lot number, udi number, and expiration date.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.

• 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: 21104284
• Report Number: 3004788213-2025-00002
• Device Sequence Number: 9118332
• Product Code: MJO
• UDI-Device Identifier: 03662663000185
• UDI-Public: (01)03662663000185(17)220501(10)5293182
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: MB3595
• Device Lot Number: 5293182
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/12/2025; 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2017
• 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: Disability; Hospitalization; Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White