MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 13X15 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

The product is not received yet.No examination was yet performed.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.Conclusion is not yet available.Investigation still in progress.

Event Description

Mobi-c p and f us: disassembly.As reported mobi-c implant was not used, endplate of implant fell off peek when loaded and was unable to be re-assembled for use without damage to hmw core of implant, a new implant was selected and used for surgery.No impact on patient reported.No surgical complication was notified.Update received on may 19th from the reporter : the techniques was instructed to the tech, she may have over threaded when loading.A second inserter was used to complete the surgery.Additional information were requested.Investigation still in progress.

Manufacturer Narrative

The product was returned to ldr medical without its decontamination form.Which prevent from initiation the decontamination process.Therefore, no product evaluation could be performed.The device history record review show no evidence on a device issue that may have impacted this event.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.It is more than likely that the tech kept screwing the implant on the implant holder, as reported in the email received on may 19th 2018 and on november 8th 2018, while she should have stopped, thus causing the opening of the jaws and implant releasing.It is clearly stated in the surgical technique to take care to stop screwing as soon as full contact is achieved in order to avoid premature opening the jaws and releasing the implant (step 9: implant assembly to the implant inserter).Moreover, it is clearly stated in the surgical technique that if at any time prior to achieving final position the implant comes apart from the peek cartridge, do not attempt to reassemble, select and use a new preassembled implant (step 11: device insertion).However , regarding that the device was returned in state that prevent it examination , and that the surgery was completed with a another inserter without providing its reference or batch number to allow the device history record review.This assumption , based on the reporter description and the recurrence of this type of event cannot be validated.The exact root cause remain undetermined with hypothesis of user error during implant assembly on inserter.If additional informations were received that allow to draw a conclusion for this case , another report will be sent.

Event Description

Mobi-c p&f us : disassembly.It was reported on the zper on (b)(6) 2018 that the mobi-c implant was not used, endplate of implant fell off peek when loaded and was unable to be re-assembled for use without damage to hmw core of implant, a new implant was selected and used for surgery.The implant record was attached for documentation.Additional information received on may 19th 2018: the mobi-c loading on inserter technique was instructed to the tech, she may have over threaded when loading.A second inserter was used to complete the surgery.Additional information received on november 8th 2018: the implant appeared to be correctly loaded and depth stop was set to zero.The reporter guessed that the tech over threaded the implant and that is what may have caused the malfunction.

• Brand Name: MOBI-C IMPLANT 13X15 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: 7544894
• MDR Text Key: 109303039
• Report Number: 3004788213-2018-00165
• 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

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3355
• Device Lot Number: 5283613
• Other Device ID Number: 010366266300000017220101105283
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 28 YR