MAUDE Adverse Event Report: LDR MEDICAL IMPLANT MOBIC M ST 15X19 H6 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3596
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	09/14/2020
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 the surgeon used the mallet to tamp the implant into place.While the implant was still connected to the inserter, the surgeon reviewed an x-ray ,and decided that he wanted to have the implant sit further back.Upon striking the inserter with the mallet, the implant disassembled in the disc space.All pieces were retrieved.A new implant was successfully used to complete the case.There were no reported impacts on the patient.
Additional Manufacturer Narrative
Corrections to d3: email address, h3, and h4.Additional information in d8 and h6: component codes, type of investigation, investigation findings, and investigation conclusions.This follow-up report is being submitted to relay additional information and initially corrected information.Summary the complaint is unrefuted for disassembly.Medical records were not provided for review.Device evaluation: the device was not returned, and no photos were provided, so an evaluation was unable to be performed.Potential cause root cause was unable to be determined.The disassembly could be attributed to off-axis forces applied during the malleting.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet 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.
Event or Problem Description
It was reported the surgeon used the mallet to tamp the implant into place.While the implant was still connected to the inserter, the surgeon reviewed an x-ray and decided he wanted to have the implant sit further back.Upon striking the inserter with the mallet, the implant disassembled in the disc space.All pieces were retrieved.A new implant was successfully used to complete the case.There were no reported impacts on the patient.

• Brand Name: IMPLANT MOBIC M ST 15X19 H6 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: 10673555
• Report Number: 3004788213-2020-00160
• Device Sequence Number: 2880949
• Product Code: MJO
• UDI-Device Identifier: 03662663000192
• UDI-Public: (01)03662663000192(17)210301(10)5267132
• 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 Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 03/01/2021
• Device Catalogue Number: MB3596
• Device Lot Number: 5267132
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR