MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 13X15 H6 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB3356

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 11/04/2020

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 address device migration.The initially implanted mobi-c device was removed.A second mobi-c device was installed, but the surgeon removed it because it was not aligned properly in the disc space because of either a vertebral body defect or aggressive drilling of the endplate.The surgeon decided to install a fusion construct instead of the mobi-c device at that level.

Event Description

It was reported that a revision surgery was performed to address device migration.The initially implanted mobi-c device was removed.A second mobi-c device was installed, but the surgeon removed it because it was not aligned properly in the disc space because of either a vertebral body defect or aggressive drilling of the endplate.The surgeon decided to install a fusion construct instead of the mobi-c device at that level.

Manufacturer Narrative

Inspection the returned device was sent to an external lab for analysis.The device was found to be within specification.Device wear is consistent with being implanted for a very short duration.No damage was detected.Potential cause the root cause was unable to be determined.This event could possibly be attributed to improper alignment during implantation.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.Device use these devices are 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 13X15 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, n/a 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: 11089938
• MDR Text Key: 224150340
• Report Number: 3004788213-2020-00240
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 03662663000017
• UDI-Public: (01)03662663000017(17)230701(10)5321849
• 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: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: MB3356
• Device Lot Number: 5331138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male