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

Model Number 05-PA-75-50

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Intraoperative Pain (2662)

Event Type  Injury  

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 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
• Type of Device: SPINAL SCREW
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette, mi
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette, mi
• Manufacturer Contact: daniel nelson ; 375 river park circle; marquette, mi ; 2264489
• MDR Report Key: 9943378
• MDR Text Key: 191568820
• Report Number: 1833824-2020-00020
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00846468052539
• UDI-Public: (01)00846468052539(10)342472
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention