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

Model Number N/A

Device Problems Disassembly (1168); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

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.Device not received yet by manufacturer.

Event Description

Mobi-c p&f us : disassembly.It was a cervical disc replacement.Implant was loaded on inserter following surgical technique.Implant disassembled while positioning implant during insertion.As described by reporter, "surgeon felt it was quite possible that he could have hit a piece of bone or got caught on a piece of tissue.This could have caused prosthesis to disassemble." it was a 2 level case and both levels were completed successfully (replaced by another implant from the same size on level with the issue).Delay 5min.Additional information was requested and investigation is in progress.

Manufacturer Narrative

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.Update received by the reporter on 19th february 2018.According to him , the disc space did not seem tight.Surgeon did remove any osteophytes before insertion.From his vantage point the disc space did appear clear.For the moment the investigation is in progress.The product has not been received by the manufacturer yet.Waiting for it no examination could be done for the moment.So far, the investigation found no evidence of a product issue.

Event Description

Mobi-c p&f us : disassembly it was a cervical disc replacement.Implant was loaded on inserter following surgical technique.Implant disassembled while positioning implant during insertion.As described by reporter, "surgeon felt it was quite possible that he could have hit a piece of bone or got caught on a piece of tissue.This could have caused prosthesis to disassemble." it was a 2 level case and both levels were completed successfully (replaced by another implant from the same size on level with the issue).Delay 5min.Additional information was requested and investigation is in progress.

Manufacturer Narrative

The 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.From information provided, based on the product history records and the review of the case during complaint meeting on (b)(6) 2018, it is assessed that the event is not device related, it is assessed that the event is due to mishandling when repositioning the prosthesis into disc space.The surgeon may have come accross a bone or something else that led to the disassemblyof the device.This case is related to the surgeon's jugement of the implant positioning and it's not related to a device problem.The investigation found no evidence to indicate device issue.The root cause is not device related.

• 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: 7279654
• MDR Text Key: 100412294
• Report Number: 3004788213-2018-00038
• 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,Followup
• Report Date: 03/11/2019

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: 09/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3595
• Device Lot Number: 5296474
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/19/2018
• Supplement Dates Manufacturer Received: 02/19/2018; 02/19/2018
• Supplement Dates FDA Received: 03/20/2018; 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 47 YR