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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT "M" STANDARD, UNKNOWN SIZE; MOBI-C CERVICAL DISC PROSTHESIS
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LDR MÉDICAL MOBI-C IMPLANT "M" STANDARD, UNKNOWN SIZE; MOBI-C CERVICAL DISC PROSTHESIS Back to Search Results
Catalog Number MB3XXX
Device Problems Mechanical Problem (1384); Failure to Osseointegrate (1863)
Patient Problem Inadequate Osseointegration (2646)
Event Type  Injury  
Manufacturer Narrative
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.Reference report 3004788213-2021-00115.
 
Event Description
It was reported a revision surgery was performed at levels c4/5 and c5/6 due to instability/pseudoarthrosis.The patient is in good condition following the revision.No further information was provided on the survey.This is report two of two for this event.
 
Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned and photos and x-rays were not provided.Device evaluation could not be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to patient factors, trauma or other operational factors.Dhr review: dhr review unable to be performed as lot numbers are not known.Device use : this device is used for treatment.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 Description
It was reported a revision surgery was performed at levels c4/5 and c5/6 due to instability/pseudoarthrosis.The patient is in good condition following the revision.No further information was provided on the survey.This is report two of two for this event.
 
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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
MDR Report Key12507366
MDR Text Key272505408
Report Number3004788213-2021-00116
Device Sequence Number1
Product Code MJO
Combination Product (y/n)N
PMA/PMN Number
P110009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup
Report Date 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMB3XXX
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age35 YR
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