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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO DEVELOPMENT PAGODA PEDICLE SCREW

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ORTHO DEVELOPMENT PAGODA PEDICLE SCREW Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 10/17/2017
Event Type  malfunction  
Event Description
Additional information was received that there were three patients, not two as originally reported.
 
Manufacturer Narrative
No revision surgeries were performed so the devices were not returned. No part or lot information was reported so no other evaluation could be performed. Due to lack of event or product specific information, this report is being submitted as one mdr. If additional relevant information is received that was not available for the initial report, a supplemental report will be filed as appropriate.
 
Event Description
It was reported that two patients had a broken screw. No revision was performed on either patient. No other information was supplied.
 
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Brand NamePAGODA
Type of DevicePEDICLE SCREW
Manufacturer (Section D)
ORTHO DEVELOPMENT
12187 s. business park drive
draper UT 84020
Manufacturer (Section G)
ORTHO DEVELOPMENT
12187 s. business park drive
draper UT 84020
Manufacturer Contact
drew weaver
12187 s. business park drive
draper, UT 84020
8015539991
MDR Report Key7024786
MDR Text Key173213524
Report Number1722511-2017-00008
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131785
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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