MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGY NON-STERILE 2 LEVEL PLATE, 30MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 58-102202030

Device Problem Material Integrity Problem (2978)

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 information on the patient.No additional information or confirmation has been given that this is a pioneer surgical technologies manufactured part.

Event Description

Our distribution partner depuy synthes reported that "it was reported that the coda 30mm plate, screw was broken and backed our past locking cam.Plate and hardware was removed and revised with new coda plate.There was patient outcome reported.".

• Brand Name: PIONEER SURGICAL TECHNOLOGY NON-STERILE 2 LEVEL PLATE, 30MM
• 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: 19014343
• MDR Text Key: 339059325
• Report Number: 1833824-2024-00052
• 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: 58-102202030
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2024
• 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