MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X17 H7 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3577
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.Reference report 3004788213-2021-00091.
Event or Problem Description
It was reported that a revision surgery was performed to replace two mobi-c implants that were not originally placed properly and were oversized, and were causing the patient pain.They were replaced with alternative disc replacements with smaller footprints.This is report two of two for this event.
Event or Problem Description
It was reported that a revision surgery was performed to replace two mobi-c implants that were not originally placed properly and were oversized, and were causing the patient pain.They were replaced with alternative disc replacements with smaller footprints.This is report two of two for this event.
Additional Manufacturer Narrative
Additional information in d4: h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device was evaluated.The articulating surfaces of the polyethylene inserts showed burnishing, pitting worn machining marks, and multidirectional scratches.The backside surfaces of the endplates showed remnants of bone.Overall, the results of the analysis are consistent with a minor wear of the polyethylene insert with no evidence of impingement damage on the endplates.Root cause: root cause was unable to be determined.Per a surgeon review, the x-rays do not provide evidence showing that the implants were improperly placed or oversized.This event could possibly be attributed to unknown patient or surgeon factors.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: IMPLANT MOBIC M ST 15X17 H7 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: 12436037
• Report Number: 3004788213-2021-00092
• Device Sequence Number: 3578982
• Product Code: MJO
• UDI-Device Identifier: 03662663000178
• UDI-Public: (01)03662663000178(17)250301(10)5361560
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2025
• Device Catalogue Number: MB3577
• Device Lot Number: 5361560
• 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: 08/09/2021
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 54 KG