• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LDR MEDICAL MOBI-C CERVICAL DISC PROSTHESIS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LDR MEDICAL MOBI-C CERVICAL DISC PROSTHESIS Back to Search Results
Model Number MB3575 (X2)
Device Problems Material Disintegration; Device Dislodged or Dislocated
Event Date 12/13/2014
Event Type  Injury  
Event Description

Revision surgery on a patient treated at 2 levels via intervertebral disc arthroplasty. Devices were removed and replaced with fusion hardware.

 
Manufacturer Narrative

(b)(4). Lot numbers are as follows: mb612k: 5425372. Mb613k: 5426332. Mb621p: 6451150. Explanted devices have been sent to an external lab for analysis. Patient experienced unusual reaction to prostheses with osteolytic changes at c5, c6, and c7.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMOBI-C CERVICAL DISC PROSTHESIS
Type of DeviceMOBI-C CERVICAL DISC
Manufacturer (Section D)
LDR MEDICAL
posieres-pres-troyes
FR 
Manufacturer (Section G)
LDR MEDICAL; HOTEL DE BUREAU
4 rue gustave eiffel
rosieres pres troyes 1043 0
FR  10430
Manufacturer Contact
ron muselman
13785 research blvd.
#200
austin , TX 78759
5123443333
MDR Report Key4390562
Report Number3004903783-2014-00023
Device Sequence Number1
Product CodeMJO
Report Source Distributor
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 12/30/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/01/2012
Device MODEL NumberMB3575 (X2)
Device LOT Number5425372
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date12/13/2014
Device Age83 mo
Date Manufacturer Received12/30/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/30/2014 Patient Sequence Number: 1
-
-