MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X15 H5 US; CERVICAL DISK PROTHESIS

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Muscular Rigidity (1968); Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send an initial report about a complaint opened on the (b)(6).Product was not returned as its still implanted.No examination can be performed.Its important to highlight that for this case two potential prothesis can be related.However, insufficient informations prevent from identifying which one is alleged.The illegible state of the sales order has only allow to identify one reference and batch (subject of the second report) the identification of the other device is in progress (subject of this report).According to the available information, the review of the device history records and traceability can not be performed clarification were requested to identify the second prothesis reference and lot number.A company representative is following up with the patient and waiting for more information about this complaint.Investigation still in progress.

Event Description

Mobi-c p&f us: implant migration and patient discomfort.It was a phone call received on (b)(6) 2018 by one of zb company representative from a patient.According to the patient, he had a first stwo level surgery on (b)(6) 2017 (c5, c6 and c7).Recently he had an x-ray and show the implant was moving toward the spinal column pushing his larynx.Patient is experiencing pinching and discomfort.Revision surgery is not scheduled at this time.The event date of this issue was not confirmed.An x-ray established on (b)(6) 2018 confirmed the issue.Patient update that he has stiff fingers.Sales order of the initial surgery allow to identify the two implanted mobi-c prothesis - however no sufficient informations allow to identify which implant is concerned by this issue.Therefore, two report are sent to the authority.A follow-up meeting with the patient doctor was set for (b)(6).No update was received since.Investigation still in progress.

Manufacturer Narrative

This medwatch is submitted to send the results of the investigation.Fields b4 ; b5 ; d1 ; d2 ; d3 ; d4 ; g4 ; g7 ; h2 ; h6 & h10 were updated.Additional information were received on february 15th 2019 : part number of the second implant was identified: the review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Product was not returned as its still implanted.No examination can be performed.Its important to highlight that for this case two potential prothesis can be related.However , insufficient informations prevent from identifiying wich one is alleged.Based on the product history records, the review of the case, the recurrence of this type of event for this implant and on the fact that the product couldn't be evaluated, the root cause of the event cannot be determined.Based on the intial surgery description, the most likely hypothesis of this event is a poor preparation of the intersomatic disc space.Requests for additional information were made and only poor response were provided.The investigation found no evidence to indicate a device issue.No conclusion can be made with available inputs.Root cause: undetermined with poor prepartion of disc space hypothesis.If additional information are received, another report will be sent.

Event Description

Mobi-c p&f us : implant migration and patient disconfort it was a phone call received on august 31 st 2018 by one of zb company representatve from a patient.According to the patient, he had a first stwo level surgery on (b)(6) 2017 ( c5, c6 and c7).Recently he had an x-ray and show the implant was moving toward the spinal colomn pushing his larynx.Patient is experiencing pinching and disconfort.Revison surgery is not scheduled at this time.The event date of this issue was not confirmed.An x-ray estabilshed on august 2018 confirmed the issue.Patient update that he has stiff fingers.Sales order of the initial surgery allow to identify the two implanted mobi-c prothesis - however no sufficent informations allow to identify which implant is concerned by this issue.Therefore, two report are sent to the authority.Additional information has been received on february 15th 2019 : part number of the second implant has been found : the review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Several follow-ups have been done and no further information has been received.

• Brand Name: MOBI-C IMPLANT 15X15 H5 US
• Type of Device: CERVICAL DISK PROTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7906445
• MDR Text Key: 121641082
• Report Number: 3004788213-2018-00318
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5285790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR