MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) PIONEER SURGICAL QUANTUM MIS CANNULATED SYSTEM, BACFUSE STANDARD PLATE, 14MM.; SPINOUS PROCESS FUSION PLATE

Model Number 83-00-14

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The device that was implanted after its expiration date was clearly labeled on the outer shelf carton as well as on the inner lid of the trays and on the patient id labels.The dhr was reviewed and this product was manufactured to specifications.Device remains implanted.

Event Description

It was discovered after spinal fusion surgery that the device that was implanted had expired approximately 4 months prior to the implantation.The device was left in the patient.

• Brand Name: PIONEER SURGICAL QUANTUM MIS CANNULATED SYSTEM, BACFUSE STANDARD PLATE, 14MM.
• Type of Device: SPINOUS PROCESS FUSION PLATE
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: dan nelson ; 375 river park circle; marquette, MI 49855 ; 9062264489
• MDR Report Key: 6219323
• MDR Text Key: 63755026
• Report Number: 1833824-2017-00001
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/29/2016
• Device Model Number: 83-00-14
• Device Catalogue Number: SAME
• Device Lot Number: 102433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1