MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X17 H5 US; CERVICAL DISC PROTHESIS

Model Number N/A

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

Product was not returned to the manufacturer, no examination was performed.According to the informations provided by the reporter, it was a mobi-c disassembly during inserter attachment.From provided description, the scrub tech accidently over tightened the inserter and released the prothesis.No impact on patient or surgery delay.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.According to the provided informations and the recurrence of this type of issue for this product range, the root cause is related to mishandling during implant assembly on inserter.As mentioned in the surgical technique " take care to stop threading as soon as full contact is achieved to avoid premature opening of the peek cartridge and releasing the implant" investigation found no evidence on a product issue.Unavailable by hospital policy.

Event Description

Mobi-c p&f us: disassembly during assembly on inserter.First description received: it was a mobi-c implant disassembled during attaching to inserter.Update received on august 20th, the scrub tech was playing around with the attached device and accidentally advanced passed zero thus releasing the pin and disengaging the implant.No patient impact or surgery delay.Surgery was completed with another device without any further issue.

• Brand Name: MOBI-C IMPLANT 15X17 H5 US
• Type of Device: CERVICAL DISC PROTHESIS
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7821769
• MDR Text Key: 118392180
• Report Number: 3004788213-2018-00290
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/28/2018

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: 09/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3575
• Device Lot Number: 5298382
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2017
• 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