MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 13X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number N/A

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Positioning Problem (3009)

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

Event Date 06/15/2018

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.Investigation still in progress.Conclusion is not yet available.Not received yet.

Event Description

As reported: implant was attached to the inserter, the inserter was set to zero.Surgeon inserted the implant into the patient and the implant ended up too far posterior as if the inserter was not set to zero.Upon trying to pull the implant back, the implant came apart.The inserter was checked and it was still set to zero.A new implant and different inserter was used.Same process and had no troubles.This complaint is about the disassembled implant.Update of (b)(6) 2018: the surgeon had distraction and when trying to slide the implant a little anterior the bottom plate and core came apart.

Event Description

It was reported that during surgery, the mobi-c implant disassembled while adjusting it in the disc space after an initial malpositioning.The surgery was completed with another implant of the same size.There was no reported patient harm or additional impact to surgery.

Manufacturer Narrative

The returned device was evaluated and confirmed for disassembly.The device returned was missing the polymer core so a full functional reassembly test was unable to be performed.It's possible the implant disassembled from the peek cartridge due to forces placed on it from the surrounding tissue during pull back to readjust the position due to inadequate distraction.Without the returned core, and without intra-op images confirming the exact positioning or integrity of the implant during the insertion and adjustment process, a cause cannot be conclusively determined.The review of the dhr records revealed no indications of manufacturing issues which would have contributed to this event.

• Brand Name: IMPLANT MOBIC M ST 13X17 H5 US
• Type of Device: MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7905637
• MDR Text Key: 121590296
• Report Number: 3004788213-2018-00247
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

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: 12/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3375
• Device Lot Number: 5303811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 04/27/2020
• Supplement Dates FDA Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1