MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 13X17 H5 US; MOBI-C CERVICAL DISC PROTHESIS

Catalog Number MB3375

Device Problems Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)

Patient Problems Pain (1994); Dysphasia (2195)

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.

Event Description

A patient reported that they have two 5mm mobi-c implants, placed at c5-c6 and c6-c7, that are too big and sitting too anterior.The patient reports that they are in pain every day and are experiencing dysphagia.A revision surgery is planned for december.This is report one of two for this event.

Event Description

A patient reported that they have two 5mm mobi-c implants, placed at c5-c6 and c6-c7, that are too big and sitting too anterior.The patient reports that they are in pain every day and are experiencing dysphagia.A successful revision surgery was performed where two 5mm tall implants were replaced with 4.5mm tall implants in the same footprint.This is report one of two for this event.

Manufacturer Narrative

H6: additional method code: 4110.Corrections in b5, d1, and d4: catalog, and lot numbers.Additional information in d4: expiration date and udi number, d6b, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned for evaluation, but an x-ray image was provided which shows that the implant is sitting too anterior in the disc space.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to the implant not being placed correctly during the initial surgery.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device usage: this device is 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.Reference report 3004788213-2023-00118.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 13X17 H5 US
• Type of Device: MOBI-C CERVICAL DISC PROTHESIS
• Manufacturer (Section D): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 18111897
• MDR Text Key: 327874111
• Report Number: 3004788213-2023-00117
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 03662663000093
• UDI-Public: (01)03662663000093(17)240701(10)5347850
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MB3375
• Device Lot Number: 5347850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2019
• 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; Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic