MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X17 H6 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Disassembly (1168); Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

Product was not received by the manufacturer.Two different description were received from the reporter with some incoherence of the event.Which prevent from identifying the alleged product reference and lot number.Without the product information it's not possible to review the traceability and the device history record to find if there is any deviation in procedures or non-conformance with specification that may have an impact on this issue.Clarification were requested to the reporter.Investigation still in progress.Conclusion is not available yet.No information about device location.

Event Description

Mobi-c p&f us : disassembly.Initial information provided is : "no charge for this implant, it fell apart when the scrub tech tightened it too far." additional information was requested but the answer wasn't consistent with the first description provided.Clarification was requested.Without clarification, there is no way to know if patient & product information provided in this additional information are related to this issue or not.Investigation is in progress.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint and its root cause following the additional information.The product was not returned to the manufacturer.Indeed, it is written in the complaint report that the product was sent through sterile processing for cleaning and did not return.Therefore, no product evaluation could be performed.From the information provided based on the product history records and the recurrence of this type of event for this product, the investigation found no evidence to indicate a device related issue.Indeed, as completed in the complaint report , the surgeon tried to reposition the implant after realizing that the implant was not correctly positionned.Indeed, it was reported that the implant was slightly off of midline.Consequently, the surgeon attempted to remove the partially implanted mobi-c and when he did the lower plate came dislodged from the peek cartridge.In the surgical technique, it is recommended to check implant assembly to peek cartridge before reinsertion if reinsertion is needed.(step 11).Indeed, according to the product manager, when the vertebral endplate's teeth penetrated into the subchondral bone, no reposition of the implant is allowed.As mentioned in the surgical technique step 11 ( during and after insertion, avoid lateral and rotational movements of the implant-to-peek cartridge assembly.) 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).Based on the available information , the root cause is related to a mishandling during implant postioning.Investigation found no evidence on adevice issue.

Event Description

Mobi-c p&f us : disassembly.First description on (b)(6) 2018: no charge for this implant, it fell apart when the scrub tech tightened it too far.Second description on (b)(6) 2018: it was reported in the complaint report that the surgeon was implanting the mobi-c partially, and when he took an a/p shot, he realized he was slightly off of midline.So, he attempted to remove the partially implanted mobi-c and when he did the lower plate came dislodged from the peek cartridge.He attempted to reassemble, but had to open a new one instead.The surgeon claimed that the implant did not let him reposition it, it fell apart and had to open a new one.That is why there was a no charge indicated.An ap shot was taken to confirm the midline positioning was off initially.Additional information received on november 5th 2018: clarification request were sent to the reporter between the first and second description.Yet, no answer was received.It is unknown whether or not the first description is related to the description reported in the complaint report.The description received in the complaint report was investigated since additional information received on november 5th 2018.It was reported that the surgeon used trials before inserting the prosthesis.The disc space was not under distraction.The uncus were released as much as possible.The mobi-c loading on inserter technique was used.It is not sure whether or not the surgeon tried to reposition the implant.The mobi-c distraction forceps were used.The mobi-c no touch level was not used.The depth stop adjustement was initially set at zero.It is unknown whether or not the prosthesis could have been inserted with an angle or if a rotational move was done while inserting the prosthesis.There was no difference in the surgical steps during the insertion of the first and second implant.The reporter believed that the implant holder removal steps were followed.Based on the available information , surgery was complited with another device of the same size.No further issue reported and no impact on patient was notified.

• Brand Name: MOBI-C IMPLANT 15X17 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 ; ZI 10300
• MDR Report Key: 7555985
• MDR Text Key: 109617949
• Report Number: 3004788213-2018-00166
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 11/23/2018

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: 09/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3576
• Device Lot Number: 5299683
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 11/05/2018
• Supplement Dates FDA Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 37 YR