MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Break (1069); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

Product is not received yet by manufacturer.No examination can be performed.The implant reference and lot number communicated were inconsistent which prevent from reviewing the device history records and traceability.Clarification were requested.No additional information received yet.The inserter reference and lot were not communicated.Additional information were requested.Conclusion is not yet available.Investigation still in progress.Device not returned.

Event Description

Mobi-c : difficulty with inserter / implant disassembly.As reported during a mobi-c surgery, the mobi-c implant broke / came apart while dr (b)(6) was trying to remove the implant holder.The implant holder would not come off with the remover.He had to replace implant which caused a delay in closure (probably about 30 min).He had to put a new implant in.As reported the same inserter was used to complete the surgery.Confirmation was asked to the reporter.Implant reference and lot number communicated are inconsistent.The instrument reference and lot number were not communicated by the reporter.Additional informations were requested.Investigation still in progress.

Manufacturer Narrative

The product was not returned.Therefore, no product evaluation could be performed.The review of the device history records of the implant did not reveal any non-conformance's to specifications or deviations in procedures that might have contributed to the reported event.From the information provided based on the complaint report , the review of the case with the product manager the recurrence of this type of event for this product, the investigation found no evidence to indicate a device related issue.Indeed, the surgeon did not follow instructions concerning the peek cartridge removal as reported on (b)(6) 2019.It is clearly stated in the surgical technique that if the peek cartridge is difficult to extract, rotate one side of the cartridge 90° caudal, then remove with forceps.Repeat on the remaining side (step 14: peek cartridge removal).Root cause : mishandling during peeka cartidge removal - instructions not followed.

Event Description

Mobi-c p&f us : disassembled and implant-holder malfunction it was reported on (b)(6) 2018 that the surgeon was not able to get the implant holder removed without the first implant coming apart.He also struggled with the second implant.It was reported on the complaint report received on (b)(6) 2018 that the mobi-c implant broke / came apart while the surgeon was trying to remove the implant holder.The implant holder would not come off with the remover.He had to replace implant which caused a delay in closure (probably about 30 min).He had to put a new implant in.Implant reference and lot number reported are inconsistent.The instrument reference and lot number were not communicated by the reporter.Additional information received on (b)(6) 2018: the complaint description was confirmed that the peek cartridge did not properly detach from the prosthesis in-situ, once in place, resulting in the entire prosthesis disassembly in-situ.Additional information received on (b)(6) 2019: the reporter did not know the reference and lot number of the implant holder, it was from the loaner tray that was shipped in to be used with surgeon at (b)(6) medical center, (b)(6) 2018.The implant holder was in the tack caddie in the tray.The reference and lot number of the implant were confirmed: mb3355 and lot# 5292815.There were no difference in the surgical steps during the insertion of the first and second implant.The depth stop adjustment of the implant holder set initially at zero.The surgical technique was followed at the mobi-c loading on inserter (take care to stop threading as soon as full contact is achieved in order to avoid premature opening of the peek cartridge and releasing the implant.).The unlocking key was used to remove the implant holder in order to release the jaws axis.The surgeon turned clockwise the unlocking key until the axis was completely released from the jaw.The following steps: while removing peek jaws if there is any resistance, one of the jaw may be against the uncus.Rotate the convex jaw first (as it is the less bulky) by 90° caudal & pull it back along the disc axis, were not followed.The surgeon did it the standard way of squeezing the holes on the sides of the implant holder.No patient impact was reported during this surgery.

• Brand Name: MOBI-C IMPLANT
• 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: 7624199
• MDR Text Key: 111834775
• Report Number: 3004788213-2018-00213
• 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: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3355
• Device Lot Number: 5292815
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 40 YR