MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 13X15 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Model Number	N/A
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	04/19/2021
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 endplate of an implant became dislodged when the cartridge was removed following recommended surgical technique.There was no reported patient impact.
Additional Manufacturer Narrative
Additional information in d4: expiration date, h4, and h6: component, investigation type, findings, and conclusions.This report is relaying additional information.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 the product was not returned and no photos were provided, so an evaluation is unable to be performed.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.Device usage this device is used for treatment.
Event or Problem Description
It was reported that the superior endplate of an implant became dislodged when the cartridge was removed following recommended surgical technique.There was no reported patient impact.

• Brand Name: IMPLANT MOBIC M ST 13X15 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, n/a 10300 ; FR 10300
• MDR Report Key: 11838893
• Report Number: 3004788213-2021-00050
• Device Sequence Number: 14238505
• Product Code: MJO
• UDI-Device Identifier: 03662663000000
• UDI-Public: (01)03662663000000(17)250701(10)5368912
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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: 07/01/2025
• Device Model Number: N/A
• Device Catalogue Number: MB3355
• Device Lot Number: 5368912
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1