MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST H5 US, UNKNOWN FOOTPRINT SIZE; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB3XX5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Headache (1880); Pain (1994); Irregular Pulse (2469); Shaking/Tremors (2515); Ambulation Difficulties (2544); Speech Disorder (4415); Fecal Incontinence (4571); Urinary Incontinence (4572)

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.Reference report 3004788213-2020-00207.

Event Description

It was reported that a patient is experiencing chronic pain, loss of grip strength and use of both hands, limited mobility, difficulty swallowing and talking, after undergoing a 2-level mobi-c procedure.The patient was scheduled to have a revision surgery to fuse c3-t1 but the procedure was canceled due to covid-19.The patient is reported to be on disability and is not able to work, and was hospitalized for irregular heartbeat associated with pain.The procedure has not been rescheduled and no further information is available at this time.This is report one of two for this event.

Event Description

It was reported that a patient is experiencing chronic pain, loss of grip strength and use of both hands, limited mobility, difficulty swallowing and talking, after undergoing a 2-level mobi-c procedure.The patient was scheduled to have a revision surgery to fuse c3-t1 but the procedure was canceled due to covid-19.The patient is reported to be on disability and is not able to work, and was hospitalized for irregular heartbeat associated with pain.The procedure has not been rescheduled at this time.This is report one of two for this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information and initially corrected information.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Manufacturer Narrative

Information added to d8, h6: component codes, health effect- impact code, health effect- clinical code, type of investigation, investigation findings, investigation conclusions this follow-up report is being submitted to relay additional information.Summary: the complaint is unrefuted for two (2) of two (2) mobi-c implants (pn unknown) for the failure of patient pain post-op due to improper product use in surgery.Medical records were provided for review and utilized to determine the failure mode.Device evaluation: product was not returned so a device evaluation could not be performed.However, per x-ray review, no misalignment or mis-sizing is noted.It can be seen, however, that the 2 mobi-c devices were implanted next to a roi-c device.Potential cause: root cause was unable to be determined.This event could possibly be attributed to the implants being used next to an roi-c, which is contra-indicated in the ifu.It is also possible that the patient's conditions prior to surgery were not alleviated and are progressing without impact from the implants.Dhr review and related actions: lot numbers are not known, so dhr review could not be performed.No actions required.This event is not related to any current actions or recalls or product holds.Device use and compatibility: this device is used for treatment.Mobi-c and roi-c implants are not indicated for use together.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that a patient is experiencing chronic pain, loss of grip strength and use of both hands, limited mobility, difficulty swallowing and talking, after undergoing a 2-level mobi-c procedure.The patient was scheduled to have a revision surgery to fuse c3-t1 but the procedure was canceled due to covid-19.The patient is reported to be on disability and is not able to work, and was hospitalized for irregular heartbeat associated with pain.The procedure has not been rescheduled at this time.This is report one of two for this event.

• Brand Name: IMPLANT MOBIC M ST H5 US, UNKNOWN FOOTPRINT SIZE
• 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
• MDR Report Key: 10943175
• MDR Text Key: 219492822
• Report Number: 3004788213-2020-00206
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MB3XX5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability