MAUDE Adverse Event Report: LDR MEDICAL IMPLANT MOBIC M ST 13X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3375
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant was returned disassembled.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.
Event or Problem Description
It was reported that during the procedure the mobi-c implant moved when the surgeon attempted to remove the peek cartridge.However, product evaluation by a zimmer biomet employee found the mobi-c implant to be disassembled.There was no reported patient harm and no further surgical information provided.

• Brand Name: IMPLANT MOBIC M ST 13X17 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 10339164
• Report Number: 3004788213-2020-00098
• Device Sequence Number: 19599372
• Product Code: MJO
• UDI-Device Identifier: 03662663000093
• UDI-Public: (01)03662663000093(17)221001(10)5301044
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: 10/01/2022
• Device Catalogue Number: MB3375
• Device Lot Number: 5301044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1