MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGY NON-STERILE 3 LEVEL PLATE, 45MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 58-102203045

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2024

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 geather data from the rep as well as the hospital that had information on the patient.

Event Description

It was reported that on an unknown date, the screw was backing out of a three level coda plate.Cervical three to cervical six, the screw was backing out of the six vertebra.Patient consequences/outcome were unknown.

• Brand Name: PIONEER SURGICAL TECHNOLOGY NON-STERILE 3 LEVEL PLATE, 45MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 357 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer Contact: gina calcaterra ; 375 river park circle; marquette, MI 49855 ; 6062269909
• MDR Report Key: 19014105
• MDR Text Key: 339046654
• Report Number: 1833824-2024-00304
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 58-102203045
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 04/01/2024
• 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