MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGY NON-STERILE 3 LEVEL PLATE, 48MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 58-102203048

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

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 on the patient.No additional information or confirmation has been given that this is a pioneer surgical technologies manufactured part.The following sections of this report have been left blank due to the information being unavailable or non-applicable: a1-a6 b3, b6, b7 d6a, d6b, d7b g5, g7, g8 h2, h7, h9, h10.

Event Description

Our distribution partner depuy synthese reported that "dps rep, nilabja dutta, states "it was reported that on an unknown date, the patient underwent an elective c3-6 anterior cervical acdf.A screw in the bottom of the construct started to back out.Patient underwent an elective acdf c 3-6".".

• Brand Name: PIONEER SURGICAL TECHNOLOGY NON-STERILE 3 LEVEL PLATE, 48MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 19014524
• MDR Text Key: 339051102
• Report Number: 1833824-2024-00051
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222493
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 58-102203048
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• 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