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

Catalog Number MB3XXX

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 05/16/2023

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

It was reported that a mobi-c implant is sitting improperly post-operatively.The patient has unknown symptoms.A revision surgery was scheduled to remove the device, but the patient cancelled the surgery.No further information is available.

Manufacturer Narrative

Corrections in g1.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned, however x-ray images were provided which show that the implant plates were misaligned.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.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 mobi-c implant is sitting improperly post-operatively.The patient has unknown symptoms.A revision surgery was scheduled to remove the device, but the patient cancelled the surgery.No further information is available.

• 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: 17082928
• MDR Text Key: 316727768
• Report Number: 3004788213-2023-00055
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P1100091
• 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: 05/17/2023
• Initial Date FDA Received: 06/07/2023
• 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): Other
• Patient Age: 44 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic