MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT HOLDER; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB9001R

Device Problem Unintended Movement (3026)

Patient Problems Nerve Damage (1979); Pain (1994); Paraplegia (2448); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/13/2022

Event Type  Injury  

Event Description

It was reported that a patient had increased leg and hand weakness post-operatively after a mobi-c device was installed.During the surgery, the surgeon felt the stop on the inserter failed to prevent the device from going too deep, so the device was removed and replaced with another mobi-c device of the same size, causing a 20 minute delay to the procedure.The procedure was a two-level mobi-c adr at c5/6 and c6/7; the level that was replaced was at c5/6.This is report two of two for this event.

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 3004788213-2022-00082.

Manufacturer Narrative

Device evaluation: product was not returned, photos were not provided, x-rays were not provided, and surgical notes were not provided.A device evaluation is unable to be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to not appropriately following the surgical technique guide, having the inserter set incorrectly, or other unknown operational or patient factors.Dhr review: dhr could not be reviewed for the mobi-c inserter as the lot number was not provided.Device use: these devices are used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

Event Description

It was reported that a patient had increased leg and hand weakness post-operatively after a mobi-c device was installed.During the surgery, the surgeon felt the stop on the inserter failed to prevent the device from going too deep, so the device was removed and replaced with another mobi-c device of the same size, causing a 20 minute delay to the procedure.The procedure was a two-level mobi-c adr at c5/6 and c6/7; the level that was replaced was at c5/6.This is report two of two for this event.

Manufacturer Narrative

This is the same patient that is associated with mdr report 3004788213-2023-00033.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 patient had increased leg and hand weakness post-operatively after a mobi-c device was installed.During the surgery, the surgeon felt the stop on the inserter failed to prevent the device from going too deep, so the device was removed and replaced with another mobi-c device of the same size, causing a 20 minute delay to the procedure.The procedure was a two-level mobi-c adr at c5/6 and c6/7; the level that was replaced was at c5/6.This is report two of two for this event.

• Brand Name: IMPLANT HOLDER
• 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: 15781150
• MDR Text Key: 303571370
• Report Number: 3004788213-2022-00090
• Device Sequence Number: 1
• Product Code: MJO
• 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,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MB9001R
• Device Lot Number: 710088407/57
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White