MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL QUANTUM MIS CANNULATED SYSTEM, BACFUSE STANDARD PLATE, 16MM; SPINOUS PROCESS FUSION PLATE

Model Number	83-00-16
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded by the hospital and will not be returned or evaluation.A dhr review was conducted and confirms the device met manufacturing specification prior to shipping from rti surgical facility.The distributor failed to review inventory to remove any expired products from the hospital.
Event or Problem Description
It was reported to rti surgical on (b)(6) 2021 that during a surgery performed on (b)(6) 2021, the surgeon implanted a bacfuse device and then immediately explanted it after realizing that the device was past its expiration date.A new device within it's validated sterility parameters was then implanted.

• Brand Name: PIONEER SURGICAL QUANTUM MIS CANNULATED SYSTEM, BACFUSE STANDARD PLATE, 16MM
• Common Device Name: SPINOUS PROCESS FUSION PLATE
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 12233983
• Report Number: 1833824-2021-00044
• Device Sequence Number: 3670466
• Product Code: KWP
• UDI-Device Identifier: 00846468047740
• UDI-Public: (01)00846468047740(17)201022(10)227521
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2020
• Device Model Number: 83-00-16
• Device Catalogue Number: 83-00-16
• Device Lot Number: 227521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other