MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 13X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initial report of this complaint.The review of the device history records is ongoing.Product was not returned yet, no evaluation could be performed.Investigation still in progress.Product not returned.

Event Description

Mobi-c p&f us : revision due to implant migration.As reported, patient came in 2 month post op and according to the surgeon findings; mobi-c had migrated via its inferior endplate 1mm into the canal.Patient is accumulated symptoms and undergoing an acdf now.Onset of neurological cord symptoms.X-rays were provided.Additional information was requested.Investigation ongoing.

Manufacturer Narrative

E4 entered in error.Correction: a1, a2 (age), b5, b6, d1, d2 (common device name), d4 (udi number), e1, e2, e3, g3, h3, h6 (patient code, and device code).Additional information: b1, b2, b7, g5 (510k), h6 (method, results, and conclusion codes).The x-rays show that one of the endplates appears to have migrated and is misaligned.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.Details on the initial surgery are not known and the device was not returned for evaluation so the cause is unable to be determined with the information provided.

Event Description

It was reported that a patient underwent a revision surgery after the implant migrated postoperatively.An acdf was preformed but no further surgical information was provided.

• Brand Name: IMPLANT MOBIC M ST 13X17 H5 US
• Type of Device: MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8770953
• MDR Text Key: 150376335
• Report Number: 3004788213-2019-00206
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 03662663000093
• UDI-Public: 03662663000093
• 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: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MB3375
• Device Lot Number: 5318842
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2020
• 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: 39 YR