MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM; Ø6.5MM X 50MM DL MIS PEDICLE SCREW ASSAY

Model Number 05-PA-65-50

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

No product was returned for this complaint as it remains in the patient, therefore no device investigation could be done.Batch information was not provided therefore no review of the manufacturing records could be done.Repeated inquiries to gather more information about this case have not resulted in any additional information beyond what is listed in this report at this time.The following sections of this report have been left blank due to the information being unavailable or nonapplicable: patient identifier, age or date of birth, sex, weight, ethnicity, race, relevant tests/laboratory data, other relevant history, implant date, explant date, concomitant medical products, if follow-up, what type, device manufacturer date, recall or correctional / removal number, usage of device.

Event Description

"tulip head disassociated from screw shaft within first 2 weeks post-operative.Unknown if this will require revision due to instability, pain, non-union.".

• Brand Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Type of Device: Ø6.5MM X 50MM DL MIS PEDICLE SCREW ASSAY
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 357 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY; 357 river park circle; marquette MI 49855
• Manufacturer Contact: cassy baij ; 357 river park circle; marquette, MI 49855 ; 9062269909
• MDR Report Key: 13169256
• MDR Text Key: 285852414
• Report Number: 1833824-2022-00100
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192396
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 05-PA-65-50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 01/05/2022
• 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