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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANET JAZZ LOCK
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IMPLANET JAZZ LOCK Back to Search Results
Model Number 150700
Device Problem No Apparent Adverse Event (3189)
Patient Problem Neurological Deficit/Dysfunction (1982)
Event Date 11/03/2017
Event Type  Injury  
Event Description
First surgery in (b)(6) 2016 for c1-c2 luxation: 2 jazz lock implanted.Revision surgery due to recurrence luxation in (b)(6) 2017.
 
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Brand Name
JAZZ LOCK
Type of Device
JAZZ LOCK
Manufacturer (Section D)
IMPLANET
technopole bordeaux montesquie
allee francois magendie
martillac, 33650, fr
Manufacturer (Section G)
IMPLANET
technopole bordeaux montesquie
allee francois magendie
martillac, 33650, fr
Manufacturer Contact
regis le couedic
technopole bordeaux montesquie
allee francois magendie
martillac, 33650
FR   33650
MDR Report Key7057739
MDR Text Key92858633
Report Number3007675554-2017-00003
Device Sequence Number1
Product Code OWI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K153348
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date02/28/2017
Device Model Number150700
Device Catalogue Number350700
Device Lot NumberGGYK-GGXL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Device Age16 MO
Date Manufacturer Received11/13/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age8 YR
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