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

Model Number	05-PA-75-50
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Intraoperative Pain (2662)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dhr was reviewed for this device and it was recorded as being manufactured to specifications.After a review of the immediate post operative films and the films at the time of the occurrence by rti surgical's medical advisor as well as a review of the returned devices, the most likely cause of this occurrence was the placement of the screw during the initial surgery allowed for the dissassociation of the screw yoke potion.If further information becomes available, pioneer surgical will update this report.It is unknown the patient's information beyond the sex.
Event or Problem Description
(b)(6) reported incident - approximately 6 weeks post-op, the patient reported pain due to a 2 level surgery from l4 to s1 with a tlif approach with cage on the left side from l5/s1.It was discovered through x-ray that head of the screw at s1 on the right side popped off.Revision surgery was conducted on an unknown date, and type of reconstruction is undetermined as of reporting date.

• Brand Name: STREAMLINE MIS, PEDICLE SCREW
• Common Device Name: SPINAL SCREW
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette, mi
• MDR Report Key: 9943378
• Report Number: 1833824-2020-00020
• Device Sequence Number: 16690353
• Product Code: NKB
• UDI-Device Identifier: 00846468052539
• UDI-Public: (01)00846468052539(10)342472
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2020

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-75-50
• Device Catalogue Number: SAME
• Device Lot Number: 342472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/09/2020
• 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: Required Intervention