MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 13X15 H6 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3595
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
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.Reference report 3004788213-2020-00242.
Event or Problem Description
It was reported that a patient lost motor signals during surgery after the surgeon removed a large herniation from the spinal cord.The surgeon installed a mobi-c implant after there were no issues with the cord or exiting nerve roots found.The patient was paralyzed after waking up in the recovery room.A revision surgery was later performed to remove the two mobi-c devices and install a fusion construct.This is report two of two for this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Additional information in h6: method, results, and conclusions.Summary.The complaint is unrefuted for two (2) of two (2) unreturned mobi-c implan (pn: mb3595) for the failure patient harm in surgery prior to implanting devices.Medical records were provided in form of x-ray.The provided x-rays show poor visualization and do not reflect the final position of the implants.No more information was shared despite attempts at due diligence.Potential cause.The cause of the patient being paralyzed can't be determined since there is no information available regarding how the operation was performed.Per the complaint description the paralyzing occurred before the surgeon implanted the devices, therefore the devices did not contribute to the event.Complaint history: a complaint history search was conducted.Dhr review and related actions.Per dhrs review, the parts were likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.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 that a patient lost motor signals during surgery after the surgeon removed a large herniation from the spinal cord.The surgeon installed a mobi-c implant after there were no issues with the cord or exiting nerve roots found.The patient was paralyzed after waking up in the recovery room.A revision surgery was later performed to remove the two mobi-c devices and install a fusion construct.This is report two of two for this event.

• Brand Name: IMPLANT MOBIC M ST 13X15 H6 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, n/a 10300 ; FR 10300
• MDR Report Key: 11084337
• Report Number: 3004788213-2020-00243
• Device Sequence Number: 3000352
• Product Code: MJO
• UDI-Device Identifier: 03662663000185
• UDI-Public: (01)03662663000185(17)241201(10)5355835
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2024
• Device Catalogue Number: MB3595
• Device Lot Number: 5355835
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 37 YR