MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 15X17 H4.5 US; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number	MB3574
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	12/29/2024
Type of Reportable Event	Malfunction
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.Reference report 3004788213-2025-00003.
Event or Problem Description
It was reported that during a surgery, the surgeon encountered excessive play with the attachment between the implant and inserter for two implants, resulting in both being dislodged from peek, with the inferior portion of the implants remaining intact to peek.The surgery was completed with a third implant, and without harm or delays.This is report two of two for this event.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the returned item matches information listed in the complaint file.Visual inspection revealed that the inferior plate (mb075k lot 5565001) and the polyethylene insert have disassembled from the peek cartridge.The superior plate (mb074k lot 5556176) was still assembled to the cartridge.The item could be fully disassembled and reassembled using si-mobc-0001 with no difficulty.Root cause: a definitive root cause could not be determined, but improper assembly on the implant holder could cause the implant to disassemble during insertion.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 a surgery, the surgeon encountered excessive play with the attachment between the implant and inserter for two implants, resulting in both being dislodged from peek, with the inferior portion of the implants remaining intact to peek.The surgery was completed with a third implant, and without harm or delays.This is report two of two for this event.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X17 H4.5 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: 21209529
• Report Number: 3004788213-2025-00004
• Device Sequence Number: 3851793
• Product Code: MJO
• UDI-Device Identifier: 03662663059084
• UDI-Public: (01)03662663059084(17)280801(10)5601390
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/03/2025

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: MB3574
• Device Lot Number: 5601390
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/09/2025
• 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
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MOBI-C INSERTER PN MB9001R LN UNKNOWN.
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic