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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
Model Number 752-6550-26A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
No revision surgery was performed so the device was not returned for evaluation. Review of the device history records notes no material nonconformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions nor labeling that may have caused or contributed to this mode of failure. A supplemental report is not anticipated unless additional relevant information is received. Should the product or additional relevant information become available, an evaluation will be conducted and a supplemental report filed with the results.
 
Event Description
During a clinical visit 21 months post surgery, the surgeon noted that one of the screws was broken. Patient reported to have soft bone. No revision was performed as the patient is doing well.
 
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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 Key7031498
MDR Text Key93047511
Report Number1722511-2017-00009
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131785
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model Number752-6550-26A
Device Lot NumberA152934
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2015
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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