MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X15 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3555
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	02/14/2022
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 the superior plate of a mobi-c implant disassembled while being impacted into the disc space.It was removed and replaced with another mobi-c implant to complete the procedure without patient impacts.
Additional Manufacturer Narrative
Corrections in d4: expiration date and udi number.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: the product was not returned and no photos were provided, so an evaluation is unable to be performed.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces applied 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 zimvie¿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 the superior plate of a mobi-c implant disassembled while being impacted into the disc space.It was removed and replaced with another mobi-c implant to complete the procedure without patient impacts.

• Brand Name: IMPLANT MOBIC M ST 15X15 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 13736979
• Report Number: 3004788213-2022-00016
• Device Sequence Number: 17410565
• Product Code: MJO
• UDI-Device Identifier: 03662663000062
• UDI-Public: (01)03662663000062(17)260201(10)5378093
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

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: 02/01/2026
• Device Catalogue Number: MB3555
• Device Lot Number: 5378093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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 Sex: Unknown