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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST, UNKNOWN SIZE; MOBI-C CERVICAL DISC PROSTHESIS
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LDR MÉDICAL IMPLANT MOBIC M ST, UNKNOWN SIZE; MOBI-C CERVICAL DISC PROSTHESIS Back to Search Results
Catalog Number MB3XXX
Device Problem Mechanical Problem (1384)
Patient Problem No Code Available (3191)
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 3004788213-2020-00214.
 
Event Description
It was reported that two mobi-c implants were not supporting correctly post-operatively, and a second surgery was performed.No further information has been provided.This is report one of two for this event.
 
Event Description
It was reported that two mobi-c implants were not supporting correctly post-operatively, and a second surgery was performed.No further information has been provided.This is report one of two for this event.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Summary: the complaint is unrefuted for two (2) of two (2) mobi-c implants (pn mb3xxx) for the failure of not causing enough support post-op, leading to revision surgery.This device is used for treatment.No medical records were provided with the complaint.Inspection: the product was not returned and no photos were provided, so an evaluation is unable to be performed.Dhr review: the lot numbers were not provided, so the dhrs are unable to be reviewed.Potential root cause: the product was not returned and no photos were provided, so an evaluation is unable to be performed.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.A follow-up report will be submitted if new information is received that changes the information provided in this report.
 
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Brand Name
IMPLANT MOBIC M ST, 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 Key10942063
MDR Text Key219492517
Report Number3004788213-2020-00213
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 consumer
Type of Report Initial,Followup
Report Date 05/05/2021
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
Device Operator Lay User/Patient
Device Catalogue NumberMB3XXX
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/04/2020
Initial Date FDA Received12/03/2020
Supplement Dates Manufacturer Received05/03/2021
Supplement Dates FDA Received05/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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