MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X19 H6 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initial report and the result of the investigation of this complaint.The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.The product location is unknown.Therefore, no product evaluation could be performed.From the information provided, the product history records, based on the review of the case and the recurrence of this type of event for this product, the root cause of the event cannot be determined.The hypothesis is that it is more than likely that the surgeon used some rotational movement to position the implant, leading to its disassembly.It was reported that it is unknown whether ot not the prosthesis could have been inserted with an angle or if a rotational move was done while inserting the prosthesis.Moreover, it was reported that the surgeon did not use the mobi-c level, whose use is to check the correct position in rotation of the implant holder.The use of the mobi-c level could have allowed a parallel insertion of the implant into the intervertebral disc space.Its use is clearly stated in the surgical technique (step 10: verify insertion trajectory).Yet, without the product return and evaluation, this hypothesis cannot be validated.The root cause is unknown with the most likely hypothesis of user error (repositioning in situ).If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

Mobi-c p&f us: disassembly.According to the reporter: the peek opened before implant was in place causing the implant to come apart prior to insertion.The surgery was completed with another device of the same size.No delay in surgery was reported.The reporter did not think that there is anything wrong with the implant: the failure was with the peek delivery mechanism.Additional information received on february 5th 2019: the patient is doing fine.A 2-level surgery was performed.The disassembly happened during insertion.The depth stop adjustment was initially set at zero.The reporter believed that the disc space was under distraction.The surgeon did not want to reposition the implant.The surgeon did not encounter resistance while inserting prosthesis.The surgical technique was followed at the mobi-c loading on inserter (take care to stop threading as soon as full contact is achieved in order to avoid premature opening of the peek cartridge and releasing the implant).No difference in surgical steps between the first and the second implant were noticed.The reporter did not know if the prosthesis could have been inserted with an angle or if a rotational move was done while inserting the prosthesis.No pre-, per- or post-op x-ray images of the surgery are available.The reference, lot and serial number of the implant inserter used during this surgery could not be provided.The surgeon used trials before inserting the prosthesis.He did not encounter the same issue with the trials.The mobi-c no touch level was not used.The mobi-c distraction forceps were used.The word up could be read on the implant holder.The superior endplate disengaged from the inserter.The implant fell out of the peek as the surgeon was beginning to implant.The carrier mechanism failed.Additional information received on 08 and 13/feb/2019: the product location is unknown.Therefore, no product evaluation could be performed.

• Brand Name: MOBI-C IMPLANT 15X19 H6 US
• Type of Device: CERVICAL DISK PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8361021
• MDR Text Key: 136907802
• Report Number: 3004788213-2019-00037
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: N/A
• Device Catalogue Number: MB3596
• Device Lot Number: 5238583
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2019
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1