MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X15 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3555
Medical Device Problem Codes	Expiration Date Error (2528); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Hearing Impairment (1881); Failure of Implant (1924); Unspecified Infection (1930); Memory Loss/Impairment (1958); Loss of Range of Motion (2032); Loss of Vision (2139); Neurogenic Shock (2265); Numbness (2415); Neck Pain (2433); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577)
Date of Event	10/30/2020
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.
Event or Problem Description
It was reported that a mobi-c patient has loss of motion due to bone spurs above and below c5/6 (where the mobi-c was implanted) and is having an allergic reaction to nickel.Patient is experiencing pain, muscle spasms, shocks, swelling, and losing feeling in arms and legs.The device remains implanted.
Additional Manufacturer Narrative
Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned and photos were not provided; device evaluation unable to be completed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review : per dhr review, the part was likely conforming when it left zimvie 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 that a mobi-c patient has loss of motion due to bone spurs above and below c5/6 (where the mobi-c was implanted) and is having an allergic reaction to nickel.Patient is experiencing pain, muscle spasms, shocks, swelling, and losing feeling in arms and legs.The device remains implanted.
Event or Problem Description
It was reported that a mobi-c patient has loss of motion due to bone spurs above and below c5/6 (where the mobi-c was implanted) and is having an allergic reaction to nickel.Patient is experiencing pain, muscle spasms, shocks, swelling, and losing feeling in arms and legs.Additional information received from the reporter indicates the mobile core migrated and a revision surgery was performed to remove the mobi-c device and replace it with cadaver bone and a plate.The patient's swelling in the legs and feet was gone within a few days after the mobi-c device was removed.
Additional Manufacturer Narrative
If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Additional Manufacturer Narrative
Additional information in b7 and h6: patient code and results.Device evaluation: product was not returned and photos were not provided; device evaluation unable to be completed.Root cause: root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review: per dhr review, the part was likely conforming when it left zimvie 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.
Event or Problem Description
It was reported that a mobi-c patient has loss of motion due to bone spurs above and below c5/6 (where the mobi-c was implanted) and is having an allergic reaction to nickel.Patient is experiencing pain, muscle spasms, shocks, swelling, and losing feeling in arms and legs.Additional information received from the reporter indicates the mobile core migrated and a revision surgery was performed to remove the mobi-c device and replace it with cadaver bone and a plate.The patient's swelling in the legs and feet was gone within a few days after the mobi-c device was removed.
Additional Manufacturer Narrative
The patient submitted voluntary medwatch mw5155778 for this event.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that a mobi-c patient has loss of motion due to bone spurs above and below c5/6 (where the mobi-c was implanted) and is having an allergic reaction to nickel.Patient is experiencing pain, muscle spasms, shocks, swelling, and losing feeling in arms and legs.Additional information received from the reporter indicates the mobile core migrated and a revision surgery was performed to remove the mobi-c device and replace it with cadaver bone and a plate.The patient's swelling in the legs and feet was gone within a few days after the mobi-c device was removed.
Additional Manufacturer Narrative
Voluntary medwatch mw5156085 was also submitted for this event.H6 additional clinical code: 4581 (for bone lesions).Additional information in h6: clinical signs.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that a mobi-c patient has loss of motion due to bone spurs above and below c5/6 (where the mobi-c was implanted) and is having an allergic reaction to nickel.Patient is experiencing pain, muscle spasms, shocks, swelling, and losing feeling in arms and legs.Additional information received from the reporter indicates the mobile core migrated and a revision surgery was performed to remove the mobi-c device and replace it with cadaver bone and a plate.The patient's swelling in the legs and feet was gone within a few days after the mobi-c device was removed.The patient also reported infection, vision loss, hearing loss, memory loss, and bone lesions, although it is not clear if these new developments occurred prior to or after the device was removed.
Additional Manufacturer Narrative
The patient submitted a follow-up report for this event; mw5156085-1.An additional two clinical codes and a new product problem code were added with this follow-up report.The patient alleges the device was expired, however, the photographic evidence provided by the reporter shows a different part and lot number than part and the lot numbers associated with this patient.According to the dhr records for the lot that was associated with this patient, it was not expired at the time of implantation.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that a mobi-c patient has loss of motion due to bone spurs above and below c5/6 (where the mobi-c was implanted) and is having an allergic reaction to nickel.Patient is experiencing pain, muscle spasms, shocks, swelling, and losing feeling in arms and legs.Additional information received from the reporter indicates the mobile core migrated and a revision surgery was performed to remove the mobi-c device and replace it with cadaver bone and a plate.The patient's swelling in the legs and feet was gone within a few days after the mobi-c device was removed.The patient also reported infection, vision loss, hearing loss, memory loss, and bone lesions, although it is not clear if these new developments occurred prior to or after the device was removed.

• Brand Name: IMPLANT MOBIC M ST 15X15 H5 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: teresa george ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035018506
• MDR Report Key: 14337235
• Report Number: 3004788213-2022-00032
• Device Sequence Number: 17477076
• Product Code: MJO
• UDI-Device Identifier: 03662663000062
• UDI-Public: (01)03662663000062(17)250101(10)5358337
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/26/2024

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: Other
• Device Expiration Date: 01/01/2025
• Device Catalogue Number: MB3555
• Device Lot Number: 5358337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 09/13/2022; 09/13/2022; 09/13/2022; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 10/01/2022; 07/25/2023; 10/30/2023; 06/11/2024; 07/31/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic