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

Catalog Number	MB3575
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that a mobi-c implant disassembled during implantation in the disc space.Imaging taken after showed it was installed showed the inferior plate was rotated 90 degrees in-situ.When the device was removed, the superior plate was still attached to the cartridge, however the poly core and inferior plate were not attached but were successfully retrieved.Another implant was opened, loaded on the same inserter, and implanted without complication.There were no patient impacts.
Event or Problem Description
It was reported that a mobi-c implant disassembled during implantation in the disc space.Imaging taken after showed it was installed showed the inferior plate was rotated 90 degrees in-situ.When the device was removed, the superior plate was still attached to the cartridge, however the poly core and inferior plate were not attached but were successfully retrieved.Another implant was opened, loaded on the same inserter, and implanted without complication.There were no patient impacts.
Additional Manufacturer Narrative
Corrections in d4: udi number, d9, and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation visual inspection revealed that the device was returned disassembled from the peek cartridge.The device was able to be reassembled without issue.The cause of disassembly could not be identified, so the product failure could not be recreated as observed during operation.Potential cause this event could possibly be attributed to inserting the device off-axis, adjusting during insertion, not turning the handle correctly during insertion or attempting to adjust the positioning while inserting the implant.Dhr review per dhr review, the part was likely conforming when it left zimvie's control.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: IMPLANT MOBIC M ST 15X17 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 13932350
• Report Number: 3004788213-2022-00026
• Device Sequence Number: 17144627
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: (01)03662663000154(17)251201(10)5376105
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2025
• Device Catalogue Number: MB3575
• Device Lot Number: 5376105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male