MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT M"STANDARD", UNKNOWN SIZE; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB2XXX

Device Problem Migration (4003)

Patient Problems Pain (1994); Paraplegia (2448)

Event Type  Injury  

Event Description

It was reported that a patient visited the emergency room with severe upper back pain and acute paraplegia.Emergent surgical exploration was performed due to the acute onset of paraplegia.During the procedure, the plates of the prosthesis had subsided into the upper and lower vertebra, but removal of both plates was possible after drilling the junction.Posterior herniation of the nucleus was detected.T1 corpectomy was performed to remove the nucleus of the prosthesis completely and safely.A titanium mesh cage filled with autologous bone was implanted and fixed using a ventral plate.The patient underwent physical therapy and occupational therapy following the emergent operation.One month after surgery, the patient could walk without assistance.

Manufacturer Narrative

G4: this device is not cleared for use in or marketed within the us, however it is a similar product to those cleared by p110009 under product code mjo.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.

• Brand Name: MOBI-C IMPLANT M"STANDARD", UNKNOWN SIZE
• Type of Device: 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: 16876866
• MDR Text Key: 314642968
• Report Number: 3004788213-2023-00040
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MB2XXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male