MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X15 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Inadequacy of Device Shape and/or Size (1583); Structural Problem (2506)

Patient Problem Failure of Implant (1924)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

Product was not returned to manufacturer yet.No examination was performed yet.Clarification were asked to identify to which of the three events is related the alleged product treated in this report.The review of the traceability and the device history records of the three implants mentioned above did not reveal any non-conformance's to specifications or deviations in procedures that might have contributed to the reported event.Investigation still in progress.Conclusion is not yet available.

Event Description

Mobi-c p&f us: disassembled and wrong size.It was the surgeon first case with mobi-c.As reported: first implant that came in and out, surgeon said that the implant was loose as we impacted with a mallet and as he tightened he took the inserter off the implant.Second implant was put in too far and as we pulled it back it fell apart.Third implant was the wrong height since surgeon used the burr in between the second and third implant.Additional informations received on june 18th : the first implant disassembled because surgeon went to retighten the inserter to the implant but tightened it too much and removed the post holding the implant to the peek cartridge.When he went to take out the implant that¿s when it fell apart.As reported: for the first implant the surgical technique was not followed because of the over tightening the post became removed from the cartridge before the implant was fully inserted.Surgery was completed with 2 roi-c implant and a 6 mm mobi-c implant.No impact on patient; delay of 30 min of the surgery.Three mobi-c implants mentioned in the complaint report from initial reporter.For the moment, not able to determine which implant matches with each problem.Clarification were asked to identify to which of the three events is related the alleged product treated in this report.Additional information requested.Investigation in progress.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.Although it was mentioned that product will be returned , it was never received by manufacture for examination it's important to highlight as it was mentioned in the previous report , that three prothesis were related to this case however the reporter d'id'nt clarify which implant corresponds to which event.Clarification were requested but no answer received.Creation of this report was according to the first chronological description provided by the reporter.The other implants potentialy related to this event are : - mb3555 lot number 5301863 ; expiry date : 01/10/2022 / mft date 28/11/2017 -mb35555 lot number 5295572 ; expiry date 01/07/2022 / mft date 3/08/2017 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.( for three implants) from information provided, based on the product history records, the review of the case and the recurrence of this type of event for this implant, the likely cause for the event is an excessive screwing while loading of prosthesis on inserter.Indeed, overtightening the inner rod that secures the implant-locking nut to the implant inserter will unscrew the locking nut from the peek holder and disassemble the device.The mobi-c surgical technique warns to stop threading (the inner rod) as soon as full contact is achieved in order to avoid opening the disposable implant holder and releasing the implant.The investigation found no evidence to indicate device issue.The root cause is a user error.

• Brand Name: MOBI-C IMPLANT 15X15 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: 7762032
• MDR Text Key: 116401458
• Report Number: 3004788213-2018-00241
• 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: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5292322
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 42 YR