MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL STREAMLINE MIS SYSTEM; PEDICLE SCREW

Model Number	05-PA-65-50
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted screw was returned to rti surgical for evaluation.Visual inspection found that the construct appears to have been locked down at a high angle.Dimensional inspection found the screw head to meet manufacturing specifications.The 0.330 diameter to the tulip opening also met manufacturing specifications.A dhr review was conducted and confirmed that this device met manufacturing specifications prior to shipping from rti surgical.
Event or Problem Description
It was reported to rti surgical on (b)(6) 2020 that a streamline mis pedicle screw tulip disassociated post-operatively.The index surgery (l1-s1) was performed on (b)(6) 2020.During post-op follow-up, x-rays confirmed that the pedicle screw at the left l5 had disassociated.Revision surgery was performed on (b)(6) 2020 to replace the screw.During the revision surgery, it was also determined that a set screw (at a different site on the left side of the construct) had loosened post-operatively.The loosened screw was replaced with a new one.The set screw is on medwatch report number, 1833824-2020-00026.

• Brand Name: PIONEER SURGICAL STREAMLINE MIS SYSTEM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette, mi
• MDR Report Key: 10271222
• Report Number: 1833824-2020-00025
• Device Sequence Number: 860117
• Product Code: NKB
• UDI-Device Identifier: 00846468052386
• UDI-Public: (01)00846468052386(10)341338
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2020

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: 05-PA-65-50
• Device Catalogue Number: SAME
• Device Lot Number: 341338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/14/2020
• 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: Hospitalization