MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 02-TL-HANDLE

Device Problem Calibration Problem (2890)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/03/2023

Event Type  Injury  

Manufacturer Narrative

Device was not returned to resolve surgical for inspection.Batch information remains unknown at this time.Multiple attempts were made to gather data from the rep.No additional information or confirmation has been given that this is a pioneer surgical technologies manufactured part.

Event Description

Surgalign reported that "the patient had surgery on (b)(6) 2023 which was a removal of existing l4-5 posterior screws and rods.Adding l5-s1 tlif, with screws and rods.When final tightening the set screws, the l5 right screw the final tightening driver tip broke off in the set screw.After surgery the patient was complaining of left pain she did not have.The surgeon decided that same pedicle screw may have been placed too laterally and may be causing the pain.Unrelated to the shaft breaking off.The final torque t-handle may have been out of calibration to cause the tip to break off.When revising the screws on the right side on saturday, he could not get that set screw loose and used 3 final torque drivers as well as a couple mis screwdriver shafts.I switched out the final torque t-handle and switched final torque drivers 3 times thinking they may have been out of calibration.It seems when final tightening occurred in previous surgery, the torque break away value was higher.Thus not allowing the final tightener shafts to loosen the set screw without breaking.Dr.Had to use a metal cutting drill to cut the rod and helicopter the screw out.It added about 15 minutes to the procedure with no harm to the patient.All parts will be returned.".

• Brand Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 17698350
• MDR Text Key: 322827388
• Report Number: 1833824-2023-00100
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192800
• 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
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02-TL-HANDLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other