MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X15 H6 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB3556

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 02/24/2022

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It was reported that a revision surgery was performed to remove a mobi-c due to a poly core failure.The surgeon declined to provide any further information so no additional information will be obtained.

Event Description

It was reported that a revision surgery was performed to remove a mobi-c due to a poly core failure.The surgeon declined to provide any further information so no additional information will be obtained.

Manufacturer Narrative

Device evaluation per the exponent report: "the articulating surface of the polyethylene insert showed burnishing and multi-directional scratches.The endplates had evidence of damage consistent with impingement.Overall, the results of the stage i analysis are consistent with a device having impingement." the location of the impingement damage on the endplates is indicative of possible kyphosis, although it is possible that any of the damage seen during inspection could have been due to the removal process during revision.With the known information, no particular failure mode could be confirmed.Potential cause root cause was unable to be determined.This event could possibly be unknown patient, surgical or post-op traumatic factors.Dhr review per dhr review, the part was likely conforming when it left zimvie control.Device use 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.

• Brand Name: IMPLANT MOBIC M ST 15X15 H6 US
• Type of Device: 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: 13840172
• MDR Text Key: 287543851
• Report Number: 3004788213-2022-00018
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 036626630000
• UDI-Public: (01)036626630000(17)240301(10)5336895
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: MB3556
• Device Lot Number: 5336895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization