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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 752-6545-11A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 05/30/2017
Event Type  malfunction  
Manufacturer Narrative
No revision surgery was performed so the device was not returned for evaluation. 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 8 months post surgery, the surgeon noted that two screws had broken on both sides of s1. No revision was performed.
 
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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 Key6980607
MDR Text Key91103296
Report Number1722511-2017-00005
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
Report Date 09/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number752-6545-11A
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 Received09/27/2017
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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