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); Positioning Problem (3009)

Patient Problem Failure of Implant (1924)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

Product was not returned to manufacturer.No examination was performed yet.Clarification were asked to identify to which of the three events is related the product treated in this report.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.Additional request were sent to the reporter, to give more clarification to this event context.Conclusion is not yet available.Device not received yet by manufacturer.

Event Description

Mobi-c p&f us : disassembled/fit.As reported : it was surgeon first case with mobi-c.Three implants were wasted during this case (three reports were send including this one).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.That implant was charged for.Second implant was put in too far and as we pulled it back it fell apart that implant was no charge and confirmed no charge by regional manager.Third implant was the wrong height since the surgeon used the burr in between the second and third implant that implant was charged for.Additional informations were received for the first disassembly: 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.In addition it was the first surgeon case with mobi-c.Surgery was completed with a roi-c implant.No impact on patient; delay of 30 min of the surgery.As reported: the surgeon was a first time user.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.Although it was mentioned by the reporter that product will be returned , it was never received by manufacturer for examination.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.It's important to highlight as it was mentioned in the previous report , that three prothesis were related to this case however the reporter didn't 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 potentially related to this event are : mb3555, lot number 5292322 ; expiry date : 01/05/2022 / mft date 20/06/2017; mb35555, lot number 5301863 ; expiry date 01/10/2022 / mft date 28/11/2017.From information provided on the zper and on the email, 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 a mistake in the choice of the size of the implant.The surgeon chose an implant with no adequate hight and when he was inserting it, he realized that it was not the right size.So he decided to implanted a new implant with reference mb3556.Indeed , as mentioned in the surgical techniques ( step 4 to 8) there are different phases that surgeon has to follow before inserting the prothesis, which prevent this kind of mishandling.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: 7827216
• MDR Text Key: 118607339
• Report Number: 3004788213-2018-00245
• 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: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5295572
• 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