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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a mobi-c device came apart during impaction into the disc space without releasing with the inserter.The device was removed and replaced with another mobi-c implant with no impact on the patient.
Event or Problem Description
It was reported that a mobi-c device came apart during impaction into the disc space without releasing with the inserter.The device was removed and replaced with another mobi-c implant with no impact on the patient.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in d4: expiration date and udi number, h4, and h6: component, investigation type, findings, and conclusions.Inspection the returned device matches the information in the complaint file and was examined.Visual inspection revealed the device has disassembled.The insert was not returned, therefore a functional evaluation could not be performed.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.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.

• 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; parc d'entreprises du grand tr; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de berlin; parc d'entreprises du grand tr; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17389815
• Report Number: 3004788213-2023-00068
• Device Sequence Number: 6780043
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: (01)03662663000154(17)260201(10)5377014
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/10/2024

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 Expiration Date: 01/31/2026
• Device Catalogue Number: MB3575
• Device Lot Number: 5377014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/25/2023
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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: 33 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic