MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY, INC DBA RTI SURGICAL PIONEER SURGICAL (D.B.A RTI SURGICAL); STANADRAD TWO LEVEL PLATE

Model Number	27-230
Medical Device Problem Codes	Material Fragmentation (1261); Material Deformation (2976)
Health Effect - Clinical Code	Intraoperative Pain (2662)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported to rti surgical that during a regularly scheduled follow-up appointment it was discovered that the cervical plate did not fully retain the screw and the screw backed out.Index surgery was on (b)(6) 2017 and revision surgery to remove the hardware was on (b)(6) 2019.The patient had no adverse effects from the construct.Even though the patient had already fused, the surgeon decided to remove all of the hardware.The devices were returned and the plates retaining springs were found to be broken.It is unknown if the break occurred while in the patient or during removal of the construct.A dhr review was completed and the device was manufactured to rti surgical specifications.
Event or Problem Description
It was reported to rti surgical that the surgeon removed the plate and screw due to the screw backing out.Patient had no adverse effects due to the screw backing out and is solidly fused.

• Brand Name: PIONEER SURGICAL (D.B.A RTI SURGICAL)
• Common Device Name: STANADRAD TWO LEVEL PLATE
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY, INC DBA RTI SURGICAL; 375 river park circle; marquette MI 49855
• MDR Report Key: 8344484
• Report Number: 1833824-2019-00008
• Device Sequence Number: 11339571
• Product Code: KWQ
• UDI-Device Identifier: 00846468050863
• UDI-Public: (01)00846468050863(10)252970
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130427
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

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 Model Number: 27-230
• Device Catalogue Number: SAME
• Device Lot Number: 252970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/15/2019
• 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: Required Intervention
• Patient Age: 72 YR