MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT, UNKNOWN SIZE; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problems Pain (1994); Weakness (2145); No Code Available (3191)

Event Date 12/28/2018

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initail report.The reference and lot number of the product is not known.The review of the device history records and traceability is not possible to perform yet.Additional informations were requested.Investigation still in progress.Conclusion not yet available.Device not returned.

Event Description

Mobi-c p&f us: revision surgery, radiculopathy.Initial surgery: (b)(6) 2018.Before first surgery, patient was complaining of left upper extremity pain only.Post-operatively, he had left arm weakness.It was particularly noticed while he was in physical therapy.Since surgery, he has done some physical therapy, and he has not done any other modalities.His bowels and bladder are okay.His walking is not affected.Artificial disk placed at c4-5 and c6-7.Surgeon believes the artificial disc needs to be removed and then do partial corpectomies at the c4 and c5 level with new fusion.Because of the partial corpectomies, the patient will need a posterior cervical foraminotomies at c3-4 and c4-5 with fusion at c4-5.Reporter also precises as reason for revision : wrong direction implanted initially.Additional information has been requested.Investigation still in progress.

Manufacturer Narrative

The device was not returned for evaluation, however, x-rays were provided showing the nerve compression that had been reported.Without product return, a full evaluation cannot be performed, however, based on the reported event, it is likely that the surgeon had incorrectly placed the implant during the initial surgery.The lot number was not provided, so the manufacturing records were unable to be reviewed.

Event Description

It was reported that following the implantation of a mobi-c device, the patient experienced weakness in his left arm.It was determined that partial nerve compression was present and the implant was facing the wrong direction.The surgeon decided to perform a revision surgery in which partial corpectomies were completed with new fusion.No further information was provided.

• Brand Name: MOBI-C IMPLANT, UNKNOWN SIZE
• 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: 8260141
• MDR Text Key: 133542037
• Report Number: 3004788213-2019-00018
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/19/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NO INFORMATION
• Device Lot Number: NO INFORMATION
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 07/20/2020
• 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: 55 YR