MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT M"STANDARD", UNKNOWN SIZE; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB3XXX

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2023

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to remove a mobi-c implant whose mobile core migrated postoperatively.The mobi-c had been initially placed at level c6-7 and underneath a two-level acdf construct at c4-6.

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.

Manufacturer Narrative

Corrections in g1.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned, so an evaluation is unable to be performed.X-ray images were provided, but clear evidence of mobile core migration can not be seen in them.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown surgical or patient factors.The fusion above the mobi-c device could have also contributed to this issue.Dhr review: the device was not returned and the lot number was not reported, therefore a dhr is unable to be located for review.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.

Event Description

It was reported that a revision surgery was performed to remove a mobi-c implant whose mobile core migrated postoperatively.The mobi-c had been initially placed at level c6-7 and underneath a two-level acdf construct at c4-6.

• Brand Name: MOBI-C IMPLANT M"STANDARD", UNKNOWN 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
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 17133919
• MDR Text Key: 317213738
• Report Number: 3004788213-2023-00060
• Device Sequence Number: 1
• Product Code: MJO
• 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
• Report Date: 05/21/2024

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
• Device Operator: Other
• Device Catalogue Number: MB3XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Age: 35 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic