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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOOGIES 5.5 X 45MM STREAMLINE MIS SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOOGIES 5.5 X 45MM STREAMLINE MIS SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 01-PA-55-45
Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2022
Event Type  malfunction  
Manufacturer Narrative
Device not inspected due to remaining in the patient. No batch information was provided, so the manufacturing records could not be investigated. Repeated inquiries to gather more information about this case have not resulted in any additional information beyond what is listed in this report at this time.
 
Event Description
During a normal patient follow-ups, the surgeon noticed on x-ray that one of the mis set screws had backed out post-op from the original implantation date of (b)(6) 2022. The distributor was sent new torque handles and final drivers on 4/2/22, but they were unfortunately not used for this original case. The distributor is checking to see if they still have the original torque handle and final driver that would have been used in this case so that we can test.
 
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Brand NamePIONEER SURGICAL TECHNOOGIES 5.5 X 45MM STREAMLINE MIS SCREW
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
PIONEER SURGICAL TECHNOLOGY
357 river park circle
marquette MI 49855
Manufacturer (Section G)
PIONEER SURGICAL TECHNOLOGY
357 river park circle
marquette MI 49855
Manufacturer Contact
cassy baij
357 river park circle
marquette, MI 49855
9062269909
MDR Report Key14593435
MDR Text Key301848459
Report Number1833824-2022-00052
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 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number01-PA-55-45
Was Device Available for Evaluation? No
Date Manufacturer Received05/05/2022
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: 06/03/2022 Patient Sequence Number: 1
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