MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY STREAMLINE OCT OCCIPTIO-CERVICO- THORACIC SYSTEM; POSTERIOR CERVICAL SCREW

Model Number 26-PA-45-30

Device Problem Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Loss of Range of Motion (2032); Multiple Fractures (4519)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

The device remains in patient and is not available for investigation.A dhr review has not been conducted or confirmed that device(s) met specification prior to shipping.This report will be updated should this information become available at a later date.

Event Description

Our distribution partner surgalign reported that "patient developed bilateral t1 pedicle fractures resulting in bilateral hand weakness.

Manufacturer Narrative

The device remains in patient and is not available for investigation.A dhr review has not been conducted or confirmed that device(s) met specification prior to shipping.This report will be updated should this information become available at a later date.

Event Description

Our distribution partner surgalign reported that "patient developed bilateral t1 pedicle fractures resulting in bilateral hand weakness".

• Brand Name: STREAMLINE OCT OCCIPTIO-CERVICO- THORACIC SYSTEM
• Type of Device: POSTERIOR CERVICAL SCREW
• 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 Key: 15536202
• MDR Text Key: 301095833
• Report Number: 1833824-2022-00123
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 26-PA-45-30
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Other