MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

This medwatch is submitted to send the initial report.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.Waiting on product return for examination.Investigation is still in progress.Conclusion is not yet available.

Event Description

Mobi-c p&f us: implant too loose on inserter.It was reported by sales rep.That during a cervical surgery: surgical tech noticed implant 15x17 h5 (mb3575) was defective on the caudal end plate of the implant as she was loading on blue handled inserter.The surgeon also agreed it didn¿t look as usual.The endplate seemed out of place and she didn¿t feel comfortable implanting and requested a new one be opened.Patient is in good standing.The defective implant never touched the patient.The depth stop adjustment set initially at zero.According to the reporter 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).No patient impact or consequence reported.Surgery was completed with another device without further complication.Investigation is in progress.

Manufacturer Narrative

The implant was examined for the caudal end plate being locked at an odd angle.A probable cause can be attributed to the surgical tech over threading the inserter knob while initially loading the implant.This would cause premature opening of the peek cartridge and release of the implant.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was reported that during the procedure the caudal end plate of the implant was misaligned when loaded onto the inserter.The surgeon requested an alternate implant, which was implanted to complete the case.There was no reported patient harm.

• Brand Name: IMPLANT MOBIC M ST 15X17 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: 8627298
• MDR Text Key: 145628124
• Report Number: 3004788213-2019-00147
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: (01)03662663000154(17)230101(10)5306468
• 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: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MB3575
• Device Lot Number: 5306468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 62 YR