MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 13X17 H7 US; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Microbial Contamination of Device (2303); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Unspecified Infection (1930); Perforation (2001); Discomfort (2330); Perforation of Esophagus (2399); No Code Available (3191)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

Fda has received a report from patient (mw5078863).Without a product return, no product evaluation can conducted.The lot number and reference of the device are unknown; therefore the device history records and traceability are can not be reviewed.Current informations are insufficient to permit a valid conclusion about the cause of this event.Additional informations were requested.Conclusion not available yet.Not returned to manufacturer.

Event Description

Mobi-c p&f us : revision due to migration implant after trauma description received from fda, report mw5078863 : " health issues following implant of mobi-c device, manifested by (b)(6) then involvement in low speed car accident fully dislodged my device : punctured my esophagus and partially severe vocal cord.It was at this time we found the infection from surgery nearly two years prior.Cultures on device showed large presence of pathogen.Furthermore the cause of second spinal surgery was documented as device failure.".

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.The product was not returned, no analysis could be performed.The review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Based on the product history records, the recurrence of this type of event for this implant and on the fact that the product couldn't be evaluated, the root cause of the event cannot be determined.No more information is available.Indeed, as reported the patient had a low speed car accident that could have caused the migration of the implant.However, for the lack of information received from the reporter this hypothesis could not be validated.Regarding the health issues following implant of mobi-c device and the infection found, no hypothesis could be made with available inputs.If any further information is found which would change or alter any conclusions or information, a follow-up report will be filled accordingly.

Event Description

Mobi-c p&f us : revision due to migration implant after trauma.According to information provided, there was health issues following implant of mobi-c device on (b)(6) 2016, then involvement in low speed car accident fully dislodged the device : punctured the esophagus of the patient and partially severe vocal cord.It was at this time when an infection was found from surgery nearly two years prior.Cultures on device showed large presence of pathogen.Furthermore the cause of second spinal surgery was documented as device failure.Update received on march 27th 2019: implant failure led to c-spine collapse and required removal.Upon removal of device, culture was performed on incision area and device and found it to be contaminated with p-acne.Serious infection has resulted in bone infection and forced patient to receive medication via picc line for several months.Continued pain, general discomfort and other negative factors are present with patient and have been present since implant of device in 2016.Additional medical intervention as removal surgery required and extensive treatment for c-spine injury due to failure and infection contracted from contaminated device in first surgery.Update received on april 02nd 2019: the initial surgery date was performed on (b)(6) 2016.The product implanted was mb3377, lot 5224532.No more information is available.

Event Description

A patient reported that they were involved in a car accident that dislodged their previously implanted mobi-c device, puncturing the esophagus and partially severing the vocal cords.During the surgery to address the device expulsion, an infection from the original surgery two years prior was found.No further information regarding the revision was provided.

Manufacturer Narrative

Correction to: a1, b1, b2, b5, b6, d1, d2 (common device name), e1, g3, g5 (pma/510k), h3.Additional information: a2, a3, a4, a5, b7, d4 (udi number), h6 (patient code, device code, results and conclusion codes).The device was not returned and pictures were not provided.Therefore, a cause cannot be established.It is possible the car accident contributed to the migration.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.Labeling was reviewed and found to give adequate descriptions of potential adverse effects.

• Brand Name: MOBI-C IMPLANT 13X17 H7 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: 7813121
• MDR Text Key: 118154487
• Report Number: 3004788213-2018-00293
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: N/A
• Device Catalogue Number: MB3377
• Device Lot Number: 5224532
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 82