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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM SETSCREW, STREAMLINE SCREW SYSTEM

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PIONEER SURGICAL TECHNOLOGY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM SETSCREW, STREAMLINE SCREW SYSTEM Back to Search Results
Model Number 01-SETSCREW
Device Problem Insufficient Information (3190)
Patient Problem Paresthesia (4421)
Event Date 06/20/2022
Event Type  Injury  
Manufacturer Narrative
The device remains in patient and is not available for investigation. A dhr review was not conducted as the batch number is unknown. This report will be updated should this information become available at a later date.
 
Event Description
Our distribution partner surgalign reported the surgeon "saw that the pedicle was broken in the caudal part by the screw compromising the exiting l5 root. We removed the l5 screw, reviewed the root, and maintained the rest of the screws and the rods". Also "the patient cannot dorsiflex his left foot, after surgery. ".
 
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Brand NameTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Type of DeviceSETSCREW, STREAMLINE SCREW SYSTEM
Manufacturer (Section D)
PIONEER SURGICAL TECHNOLOGY
375 river park circle
marquette MI 49855
Manufacturer (Section G)
PIONEER SURGICAL TECHNOLOGY
375 river park circle
marquette MI 49855
Manufacturer Contact
lyndsey rivord
375 river park circle
marquette, MI 49855
MDR Report Key15249196
MDR Text Key298130282
Report Number1833824-2022-00073
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192396
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number01-SETSCREW
Was Device Available for Evaluation? No
Date Manufacturer Received07/25/2022
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

Patient Treatment Data
Date Received: 08/18/2022 Patient Sequence Number: 1
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