MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

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	10/12/2022
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 a mobi-c implant detached from the peek cartridge while the surgeon was rotating the implant intraoperatively.It was removed and another mobi-c implant was used to complete the case.There was no impact to the patient.
Event or Problem Description
It was reported that a mobi-c implant detached from the peek cartridge while the surgeon was rotating the implant intraoperatively.It was removed and another mobi-c implant was used to complete the case.There was no impact to the patient.
Additional Manufacturer Narrative
Inspection: the product was not returned and no photos were provided, so an evaluation is unable to 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.This event could possibly be attributed to inserting the device off-axis, adjusting during insertion, not turning the handle correctly during insertion or attempting to adjust the positioning while inserting the implant.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: IMPLANT MOBIC M ST 15X17 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: 15780530
• Report Number: 3004788213-2022-00091
• Device Sequence Number: 15117699
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: (01)03662663000154(17)251101(10)5374404
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 04/21/2023

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: 11/01/2025
• Device Catalogue Number: MB3575
• Device Lot Number: 5374404
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2020
• 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