MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 17X19 H5 US; MOBI-C CERVICAL DISC PROTHESIS

Catalog Number	MB3795
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the insertion of a mobi-c implant, the peek cartridge disassembled and resulted in early deployment of the device.Rather than rebuild and reattach, they decided to use another implant to complete the procedure.There was no patient impact.
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.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned item matches information listed in the complaint file.Visual inspection revealed that the inferior plate (mb125k lot 5400970), the polyethylene insert, and the superior plate (mb084k lot 5402598) have disassembled from the peek cartridge.The post was not returned, therefore a functional inspection could not be performed.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to improper attachment to the inserter.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.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 during the insertion of a mobi-c implant, the peek cartridge disassembled and resulted in early deployment of the device.Rather than rebuild and reattach, they decided to use another implant to complete the procedure.There was no patient impact.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 17X19 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: 19840842
• Report Number: 3004788213-2024-00062
• Device Sequence Number: 7676020
• Product Code: MJO
• UDI-Device Identifier: 03662663002042
• UDI-Public: (01)03662663002042(17)270401(10)5411307
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MB3795
• Device Lot Number: 5411307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/26/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic