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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) STREAMLINE OCT NAVIGATED INSTRUMENTS NAVIGATIONAL INSTRUMENTATION

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PIONEER SURGICAL (D.B.A. RTI SURGICAL) STREAMLINE OCT NAVIGATED INSTRUMENTS NAVIGATIONAL INSTRUMENTATION Back to Search Results
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/11/2020
Event Type  malfunction  
Manufacturer Narrative
Product was recalled under 1833824-10/01/20-0002-r.
 
Event Description
A pioneer surgical technology distributor reported that a streamline oct navigated instrument set did not include a drill guide. This was observed during a set review and not during a surgery.
 
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Brand NameSTREAMLINE OCT NAVIGATED INSTRUMENTS
Type of DeviceNAVIGATIONAL INSTRUMENTATION
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 Key10623067
MDR Text Key241412782
Report Number1833824-2020-00080
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200095
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/02/2020 Patient Sequence Number: 1
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