MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X15 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Dysphagia/ Odynophagia (1815); Tissue Damage (2104); No Code Available (3191)

Event Date 10/22/2018

Event Type  Injury  

Manufacturer Narrative

Product was not returned to ldr medical yet.No visual and functional examination can be performed.The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Investigation still in progress.Attempts to obtain more information have been made.Conclusion not yet available.

Event Description

Mobi-c p&f us: expulsion of implant.The surgeon informed the reporter of this patient, where the lateral x-ray showed a expulsion of the mobi-c device.The device was removed in a revision surgery on (b)(6) 2018.Attempts have been made to obtain more information about this case.

Manufacturer Narrative

Corrections: a1, a2 (age), b1, b2, b3, b5, b6, b7, d1, d2 (common device name), d10, e1, e2, e3, g3, h3, h6 (method codes).Additional information: a5, d4 (udi number), g5 (pma/510k), h6 (patient code, results and conclusion codes).The device was not returned for evaluation.However, x-rays were provided and used for evaluation.The x-rays confirmed expulsion of the mobi-c implant.With the given images and information, and without the returned device, a cause cannot be conclusively determined.A review of the dhr did not identify any issues which would have contributed to this event.

Event Description

It was reported that a mobi-c implant migrated post-operatively leading to a revision surgery.The implant was removed and replaced with a non-zimmer biomet fusion device.There were no further patient or surgical impacts reported.

• Brand Name: IMPLANT MOBIC M ST 15X15 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 10300 ; FR 10300
• MDR Report Key: 8019145
• MDR Text Key: 125471134
• Report Number: 3004788213-2018-00351
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5284973
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 66