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

Model Number N/A

Device Problems Detachment Of Device Component (1104); Positioning Problem (3009)

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

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

Product was not returned to ldr medical, no examination can be performed.Review of traceability and 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.Device not returned as discarded.

Event Description

As reported during a mobi-c surgery : "the surgeon was beginning to implant the mobi-c implant, and he quickly realized the implant was not midline on the vertebral bodies, and he pulled back the entire inserter and the lower mobi-c plate fell apart from the assembly.There was an attempt to reattach the lower plate back on to the assembly, but it did not work.So, a new implant had to be opened.Appropriate distraction was used the entire time".No harm to the patient.No delay superior to 30 min.No other information provided.Additional information requested.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint following the additional information received.As the product was not returned to the manufacturer, no product evaluation could be performed.From the information provided based on the complaint report , 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 positioned.Indeed, it was reported that the implant was not midline on the vertebral bodies.Consequently, the surgeon removed the entire inserter causing the disassembly of the inferior vertebral endplate.According to the product range manager , it is recommended to not reposition the prosthesis before releasing it.Indeed, when the vertebral endplate's teeth penetrated into the subchondral bone, no reposition of the implant is recommended.As mentioned in the surgical technique step 11 that during and after insertion , avoid lateral and rotational movement 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: prosthesis insertion).Based on the available information , root cause is mishandling during implant positioning (possible rotational move, absence of mobi-c level use, possible absence of distraction and redistraction).Investigation found no evidence on a device issue.

Event Description

Mobi-c p&f us : disassembly during repositionning.It was reported on the initial complaint report that the surgeon claimed that the implant did not let him reposition it, instead it fell apart and the surgeon had to open a new one.That is why there was a no charge indicated.Additional information received on april 30th 2018: the surgeon was beginning to implant the mobi-c implant, and he quickly realized the implant was not midline on the vertebral bodies, and he pulled back the entire inserter and the lower mobi-c plate fell apart from the assembly.There was an attempt to reattach the lower plate back on to the assembly, but it did not work.So, a new implant had to be opened.Appropriate distraction was used the entire time.The surgical technique was utilized properly.As the surgeon began to implant the mobi-c implant, he checked with the c-arm to verify proper lateral and anterio-posterior positioning.Once the surgeon realized the implant was not midline, he had to pull it back out.It was only partially implanted and distraction remained open the entire time.Additional information received on november 5th 2018: no pre-op, per-op or post-op x-ray images could be sent.The reporter does not think that the surgeon encountered resistance while inserting the prosthesis.The surgeon used trials before inserting the prosthesis.The reporter does not know if the disc space was under distraction.The reporter does not know if the surgeon redistract the intervertebral disc space before pulling back the implant.The mobi-c loading on inserter technique was used.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.The reporter does not know 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 implant holder removal steps were followed.

• 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: 7509930
• MDR Text Key: 108087529
• Report Number: 3004788213-2018-00150
• 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: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5280645
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 44 YR