MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 15X17 H5 US; MOBI-C CERVICAL DISC PROTHESIS

Catalog Number	MB3575
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to remove two mobi-c devices after the patient was showing signs of an allergic reaction.Although the patient is not allergic to nickel, an allergy to the mobi-c was confirmed when the doctor taped a demo implant to the patient's arm, and within 30 minutes, the site was turning red and itching.This is report two of two for this event.
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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.Reference report 3004788213-2024-00009.
Event or Problem Description
It was reported that a revision surgery was performed to remove two mobi-c devices after the patient was showing signs of an allergic reaction.Although the patient is not allergic to nickel, an allergy to the mobi-c was confirmed when the doctor taped a demo implant to the patient's arm, and within 30 minutes, the site was turning red and itching.This is report two of two for this event.
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.
Event or Problem Description
It was reported that a revision surgery was performed to remove two mobi-c devices after the patient was showing signs of an allergic reaction.Although the patient is not allergic to nickel, an allergy to the mobi-c was confirmed when the doctor taped a demo implant to the patient's arm, and within 30 minutes, the site was turning red and itching.This is report two of two for this event.
Event or Problem Description
It was reported that a revision surgery was performed to remove two mobi-c devices after the patient was showing signs of an allergic reaction.Although the patient is not allergic to nickel, an allergy to the mobi-c was confirmed when the doctor taped a demo implant to the patient's arm, and within 30 minutes, the site was turning red and itching.This is report two of two for this event.
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
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.H6: additional method code: 4110.Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the device was sent to exponent for evaluation.The articulating surface of the polyethylene inserts showed machining marks, pitting and multidirectional scratches consistent with minimal wear.The device components did not have evidence of damage consistent with impingement.Overall, the results of the stage i analysis are consistent with a device having impingement and a short implantation time.Stage iii analysis was conducted to assess the condition of the polyethylene insert.Stage iii analysis found a low (oi < 1) oxidation and mechanical properties consistent with this level of oxidation.No images of the allergic reaction were attached.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown surgical or patient factors.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s 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 revision surgery was performed to remove two mobi-c devices after the patient was showing signs of an allergic reaction.Although the patient is not allergic to nickel, an allergy to the mobi-c was confirmed when the doctor taped a demo implant to the patient's arm, and within 30 minutes, the site was turning red and itching.This is report two of two for this event.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X17 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROTHESIS
• Manufacturer (Section D): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 18699624
• Report Number: 3004788213-2024-00010
• Device Sequence Number: 17690634
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: (01)03662663000154(17)251101(10)5372870
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/25/2024

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: Lay User/Patient
• Device Expiration Date: 12/17/2020
• Device Catalogue Number: MB3575
• Device Lot Number: 5372870
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/28/2024; 08/08/2024; 11/19/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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; Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic