MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X17 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Mechanical Problem (1384); Sticking (1597)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation can be conducted.The review of the inspection records and traceability is in progress to find any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Current information is insufficient to permit a valid conclusion about the cause of this event.Investigation is in progress.Discarded by hospital.

Event Description

Mobi-c p and f us : device malfunction.Description received from distributor : while trying to release cartridge from implant, the cartridge got stuck and pulled the implant out.As a result a new implant from the same lot number was used without any issue.Update received on march 29th 2018 from distributor : cartridge did release off the implant.Surgical technique followed.Disc space was under distraction.Surgeon encountered resistance while inserting prosthesis.The implant was not inserted with an angle, it was inserted straight in.The reporter did not notice any difference between the first and the second implant.According to the reporter, the surgical technique were followed while removing the peek and probably one of the jaw could be against the uncus.No impact on patient was reported.No surgery complication or delay were notified.Investigation still in progress.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.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.From the information initially provided, the cause for the event cannot be determined.Based on the product history records, and on the recurrence of this type of event for this implant, the investigation found no evidence to indicate a device issue.As mentioned a potential contact with the uncus , and the resistance felt by the surgeon may have caused the disassembly.Indeed, in this case , the surgical technique recomand to rotate one side of the cartidge 90° caudal , then to remove with the forceps and to repeat the action on the remaining side ( step 14).However due to the absence of the actual device analysis , the exact root cause cannot be identified.If additional information was received another report will be sent.

Event Description

Mobi-c p&f us : disassembly during peek cartidge removal description received from distributor : while trying to release cartridge from implant, the cartridge got stuck and pulled the implant out.As a result a new implant from the same lot number was used without any issue.Update received on march 29th 2018 from distributor : cartridge did release off the implant.Surgical technique followed.Disc space was under distraction.Surgeon encountered resistance while inserting prosthesis.The implant was not insterted with an angle, it was inserted straight in.The reporter did not notice any difference between the first and the second implant.According to the reporter, the surgical technique were followed while removing the peekand probably one of the jaw could be against the uncus.No impact on patient was reported.No surgery complication or delay were notified.Surgery was completed with another device of the same ref and lot no update received for this case.

• Brand Name: MOBI-C IMPLANT 15X17 H5 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
• MDR Report Key: 7406071
• MDR Text Key: 104667885
• Report Number: 3004788213-2018-00099
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3575
• Device Lot Number: 5294271
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 54 YR