MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) PIONEER SURGICAL ASPECT ANTERIOR CERVICAL SCREW, 4.0MM X 16MM

Model Number	27-40-VSD-16
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the angulation of the screw and that the surgeon did not fully affix the driver to the screw for the extraction, it made it difficult to remove this implant.According to the sales rep, the surgeon was instructed on how to remove these screws but chose to not follow pioneer surgical's defined surgical technique.This resulted in the difficulting in the screw removal and the extended surgery time.
Event or Problem Description
During a three level acdf surgery, the surgeon noticed that the plate was not positioned correctly.When he tried to back out the screws to reposition this cervical plate, he had difficulty removing the final screw due to the angle at which it was placed.This resulted in a 75 minute delay in surgery while he tried to remove this screw.He was finally able to remove this screw and plate and the surgery was completed successfully.The delay in surgery did not have any adverse effect on the patient.

• Brand Name: PIONEER SURGICAL ASPECT ANTERIOR CERVICAL SCREW, 4.0MM X 16MM
• Common Device Name: ANTERIOR CERVICAL SCREW
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 6113004
• Report Number: 1833824-2016-00037
• Device Sequence Number: 16234114
• Product Code: KWQ
• UDI-Device Identifier: 00846468051181
• UDI-Public: (01)00846468051181(10)238966
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K130427
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 27-40-VSD-16
• Device Catalogue Number: SAME
• Device Lot Number: 238966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2016
• Initial Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 27-351 LOT # 198688; 27-40-VSD-16, LOT # 168909