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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 MIS SYSTEM PEDICLE SCREW,

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PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL STREAMLINE MIS SYSTEM PEDICLE SCREW, Back to Search Results
Model Number 05-PA-65-45
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/11/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to rti surgical missing the pedicle screw portion. Visual inspections found the device to be free from damage and the core tabs exhibit normal wear. A dhr review was conducted and confirms this device met manufacturing specifications prior to shipping from rti surgical.

 
Event Description

It was reported to rti surgical on (b)(6) 2020 that during a surgery, the threads of the screw broke off in the patient and could not be retrieved. Due to the broken threads, the surgeon skipped that level in surgery.

 
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Brand NamePIONEER SURGICAL STREAMLINE MIS SYSTEM
Type of DevicePEDICLE 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
daniel nelson
375 river park circle
marquette, MI 49855
MDR Report Key10977770
MDR Text Key220501467
Report Number1833824-2020-00096
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 12/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number05-PA-65-45
Device Catalogue NumberSAME
Device LOT Number375161
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/16/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/21/2020
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: 12/09/2020 Patient Sequence Number: 1
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