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	01/21/2022
Type of Reportable Event	Malfunction
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 zimmer biomet¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to twisting during insertion or adjustments after placement.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 a mobi-c implant disassembled after being installed: the surgeon had implanted the device and the inferior plate looked dislodged and tilted on the anterior portion next to the endplate.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: 13497875
• Report Number: 3004788213-2022-00011
• Device Sequence Number: 11938387
• Product Code: MJO
• UDI-Device Identifier: 03662663000062
• UDI-Public: (01)03662663000062(17)241001(10)5351578
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2022

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: 10/01/2024
• Device Catalogue Number: MB3555
• Device Lot Number: 5351578
• 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: 01/28/2022
• Initial Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• 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: Male