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

Catalog Number	MB3356
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• 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
• 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
• Report Number: 3004788213-2020-00240
• Device Sequence Number: 16827133
• Product Code: MJO
• UDI-Device Identifier: 03662663000017
• UDI-Public: (01)03662663000017(17)230701(10)5321849
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male