MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT "M" STANDARD 17X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB3775

Device Problem Malposition of Device (2616)

Patient Problems Nerve Damage (1979); Pain (1994); Neck Pain (2433); Paraplegia (2448); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/13/2022

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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.

Event Description

It was reported that a patient had post-operative complications and pain in the recovery room after a mobi-c device was installed.During the surgery, the surgeon felt the position of the implant was unacceptable, so it was removed and replaced with another mobi-c device of the same size, causing a 20 minute delay to the procedure.

Manufacturer Narrative

If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference report 3004788213-2022-00090.

Event Description

It was reported the 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 one of two for this event.

Event Description

It was reported the 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 one of two for this event.

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 per dhr review, the part was likely conforming when it left zimvie control.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 the 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 one of two for this event.

Manufacturer Narrative

Additional information in h6: clinical code.This is the same patient that is associated with mdr report 3004788213-2023-00033.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

Manufacturer Narrative

D4 udi number: (b)(4).Additional information: voluntary medwatch mw5145996 was received and is associated with this event.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 the 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 one of two for this event.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 17X17 H5 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: 15606177
• MDR Text Key: 301734244
• Report Number: 3004788213-2022-00082
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 03662663002011
• UDI-Public: (01)03662663002011(17)260201(10)5377029
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110009
• Exemption Number: 5645646
• 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,Followup,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MB3775
• Device Lot Number: 5377029 OR 5377028
• Was Device Available for Evaluation?: No
• 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?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: White