MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C PLUG & FIT US; STERILE CERVICAL DISC PROSTHESIS

Model Number N/A

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

Patient Problems Neck Pain (2433); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send an initial report about a complaint opened on the 30th of august 2018 the review of the device history records was impossible seeing that the reference and lot number are unknown to the reporter.Request were made to identify the product informations.Information requests are in progress to obtain more information about the incident and about the device.Investigation still in progress.Conclusion not yet available.

Event Description

Mobi-c p and f us : revision due to migration patient was initially implanted with a mobi-c on (b)(6) 2016.Then, it was reported that after an mri examination done on (b)(6) 2018 the surgeon became aware of the explantation of the device.The mobile core was completely out of the core space between plates and plates were collapsed onto each other, core was resting on anterior body at c6 level.Patient had a revision surgery on (b)(6) 2018 , the prothesis was explanted and replaced with another device ( not ldr product).Surgery was completed without any issue.Patient state of health is good on one mont post-op.No additional informations were received as the reporter was not the sales representative who covered the first surgery.Investigation still in progress.

Event Description

Mobi-c disassembly : in november of 2016, dr.Bisson implanted a mobi-c device in a patient.On the 17th of august the surgeon did an mri and saw that device was expulsed from it's natural position.The core of the mobi-c device was not between the two endplates, the plates were collapsed onto each other and the core was resting on anterior body of the c6.The surgeon did a revision and removed the mobi-c and then performed an acdf on the patien with a non zimmer biomet device.Further questions were asked to the reporter who confirmed that the patient is doing well and he does not know what happened because he was not the representative of the original surgery (2 years ago).Yet he did send a 1 month post-op picture of the original surgery and it is clear that the device was not in its perfect position.Further more, the reporter sent pictures of the device and the mobile core of the implant was missing a piece, it was confirmed by the reporter that the piece was found and removed from the patient.

Manufacturer Narrative

This follow-up medwatch is submitted to send the result of the investigation of this complaint.The review of the device history records of the implant and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.From information provided, based on the product history records and the recurrence of this type of event for this implant, it was assessed that the cause of the event is not device related.The real root cause is unknown but from the 1 month post-op image sent by the reporter it is clear that the surgeon did not use the right hight of implant (size) which led to the device being crushed by the vertebras and in result expulsing the core.However, according to the available data this assumption canot be validated and root cause remain unknown.The patient was revised to fusion using another non zimmer biomet device.The investigation found no evidence to indicate device issue.Root cause : unknown with hypothesis of user error (during initial surgery).

• Brand Name: MOBI-C PLUG & FIT US
• Type of Device: STERILE 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: 7908979
• MDR Text Key: 121710567
• Report Number: 3004788213-2018-00315
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 526434
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 80