MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X15 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

Device not yet received by manufacturer.

Event Description

Mobi-c p&f us : disassembly.Mobile insert came loose & became disloged prior to insertion.New implant were implanted successfully (same size).No harm to the patient.Additional information given : the implant "had been properly inserted on the driver when the surgical tech accidentally bumped a metal sterilization basket ".Probable cause is user error.Device returned but not received yet.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.

Manufacturer Narrative

Product was returned to the manufacturer.A visual examination was performed.Marks were found on the implant which reveal a potential shock.The inserter was dislodged from the implant.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 the review of the case and the product evaluation concluded to a disassembly caused by a shock which is consistent with the description received of the event.As mentioned by the reporter the inserter was dislodged because of an accidental knock of the implant on a metal sterilization basket.The surgeon made a choice to continue the surgery with a same size implant.No impact on the patient and no delay of the surgery superior of 30 min was reported.The investigation found no evidence to a product issue.The root cause of the event is a false maneuver during the assembly of the implant on the inserter ( user error).

Event Description

Mobi-c p&f us: disassembly.

• Brand Name: MOBI-C IMPLANT 15X15 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
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: florence chapaud ; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300 ; 3310648075
• MDR Report Key: 6899925
• MDR Text Key: 89390745
• Report Number: 3004788213-2017-00110
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

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: 04/01/2020
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5246453
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 11/24/2017
• Supplement Dates FDA Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 59