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
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Migration (4003)
Health Effect - Clinical Codes	No Information (3190); No Code Available (3191)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004788213-2019-00206
• Device Sequence Number: 16655002
• Product Code: MJO
• UDI-Device Identifier: 03662663000093
• UDI-Public: 03662663000093
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 39 YR