MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X19 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2018

Event Type  Injury  

Manufacturer Narrative

The product was not returned to ldr medical yet.Attempts have been made to return the product but it not received yet.The review of the device history records and the traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Attempts to obtain more information about this issue have been made.Investigation still in progress.Conclusion not yet available.

Event Description

Mobi-c p&f us : disassembled during insertion.According to the reporter: mobi-c came apart, simply loosened up.The surgical technique was followed.No impact on the patient.No delay of more than 30 min.Additional information received on oct.12th 2018 from reporter: patient is fine.Implant loosened when just touched disc space, no impaction.Surgeon didn't attempt to reposition implant.Inserter was set to zero initially.All steps followed and same tech they always work with.There was a distraction.Surgeon didn't have resistance during insertion.No angle changed.Same steps followed on second disc without issue.No xrays available.It was a two level case and all else went great.Surgeon used forceps.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint following the additional information and product return.The review of the device history records and the traceability did not reveal any non-conformance's to specifications or deviations in procedures that might have contributed to the reported event.The product was received on (b)(6) 2019.A visual examination of the product was performed.It was observed that two peek cartridges were sent to the manufacturer.The reporter informed on (b)(6) 2019 that he did not know why.Product evaluation was performed by the product manager on (b)(6) 2019.A functional analysis was processed, whose results are the following: the peek cartridge assembles and disassembles following the design specifications the peek cartridge and implant assemble and release with the inserter mb9001r.Following the design specifications.There is no trace of damage.From the information provided based on the zper, the product history records, the review of the case during complaint meeting on (b)(6) 2019, the recurrence of this type of event for this product and after having performed the product evaluation, the investigation found the cause is a user error.Indeed, considering functional analysis which was compliant, it is more than likely an incorrect implant loading on inserter was performed during the surgery.It is clearly stated in the surgical technique to visually inspect the implant assembly while loading to the universal inserter (implant inserter; mb9001r).It is normal to have a little movement in the implant attachment to the peek cartridge, particularly in the superior endplate.Concerning premature opening of the peek cartridge, it is clearly stated to take care to stop threading as soon as full contact is achieved to avoid premature opening of the peek cartridge and releasing the implant (step 9: implant assembly to the implant inserter).The investigation found no evidence to indicate a device related issue.Root cause: user error during loading the implant on the inserter.

Event Description

Mobi-c p&f us : disassembled during insertion according to the reporter: mobi-c came apart, simply loosened up.The surgical technique was followed.No impact on the patient.No delay of more than 30min.Additional information received on oct.12th 2018 from reporter : patient is fine.Implant loosened when just touched disc space, no impaction.Surgeon didn't attempt to reposition implant.Inserter was set to zero initially.All surgical technique steps followed and same tech they always work with.There was a distraction.Surgeon didn't have resistance during insertion.No angle changed.Same steps followed on second disc without issue.No xrays available.It was a two level case and all else went great.Surgeon used forceps additional information received from reporter on january 14th 2019: trials were used.The word "up" on the inserter was in the window.The tech just was looking to make sure the dial was on zero and turned the back knob and loosened it up.The surgeon used the mobi-c no touch level.Additional information received from reporter on (b)(6) 2019: instruments were not the issue.No information concerning the inserter will be provided: the reporter could not guess the implant or set it came from.The implant did seem to be loose from the start.Dr.Patel has the room dark except for his bed light, which makes it challenging when losing the implant.Product returned on 29/jan/2019 to perform evaluation.

• Brand Name: MOBI-C IMPLANT 15X19 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: 8022852
• MDR Text Key: 125590436
• Report Number: 3004788213-2018-00359
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MB3595
• Device Lot Number: 5268795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 38 YR