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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL STREAMLINE OCT SPINAL SET SCREW LOCKING SET SCREW

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PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL STREAMLINE OCT SPINAL SET SCREW LOCKING SET SCREW Back to Search Results
Model Number 26-SETSCREW
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2016
Event Type  malfunction  
Manufacturer Narrative
The spinal construct was difficult to lock down since the pedicle screws were placed to close together. This caused the surgeon to have difficulty in locking down the set screws that secure the spinal rod in place. The set screws that were returned to rti surgical were inspected and the features that were not damaged were inspected and found to be within specifications. However, some features were not able to be inspected since they were damaged during surgery.
 
Event Description
During a posterior spinal rod fusion surgery the surgeon had difficulty locking the set screws onto the construct. These set screws were removed during the surgery and replaced. Surgery was completed successfully. This difficulty delayed the surgery for approximately 1 hour but did not have any affect on the patient.
 
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Brand NamePIONEER SURGICAL STREAMLINE OCT SPINAL SET SCREW
Type of DeviceLOCKING SET SCREW
Manufacturer (Section D)
PIONEER SURGICAL (D.B.A. RTI SURGICAL)
375 river park circle
marquette MI 49855
Manufacturer (Section G)
PIONEER SURGICAL (D.B.A. RTI SURGICAL)
375 river park circle
marquette MI 49855
Manufacturer Contact
dan nelson
375 river park circle
marquette, MI 49855
9062264489
MDR Report Key5900842
MDR Text Key52899489
Report Number1833824-2016-00031
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150254
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 08/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number26-SETSCREW
Device Catalogue Number26-SETSCREW
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2016
Was Device Evaluated by Manufacturer? Yes
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: 08/24/2016 Patient Sequence Number: 1
Treatment
OCT PEDICLE SCREWS
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