Streamline® MIS Spinal Fixation System 05-FINALDRIVERRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00846468050658), received between Jun 30, 2017 and Dec 9, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 11/10/2025. IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON (B)(6) 2025 A SYSTEM POLYAXIAL SCREW HAD A MALFUNCTION IN WHICH THE IMPLANT SCREW SHANK SEPARATED FROM THE TULIP HEAD OF THE IMPLANT. THE IMPLANT SCREW ALREADY HAD THE ASSOCIATED ROD PLACED AND LOCKED INTO THE SCREW WHEN THE MALFUNCTION OCCURRED. IN AN ATTEMPT TO UTILIZE THE ROD, THE SURGEON ATTEMPTED TO LOOSEN THE REMOVED IMPLANT CONSTRUCT. DURING THE DISASSEMBLY OF THE IMPLANT CONSTRUCT OUTSIDE OF THE SURGICAL SITE THE DISTAL TIP OF A SYSTEM SCREWDRIVER WAS BROKEN. THE SHANK OF THE BROKEN SCREW WAS REMOVED, AND THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED BY IMPLANTING AN ALTERNATE AVAILABLE IMPLANT WITHOUT KNOWN COMPLICATIONS. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT AND IMPLANT, WHICH WERE RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 11/11/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23761753 ↗
• MalfunctionJul 17, 2025Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2025. IT WAS REPORTED THAT FINAL TIGHTENING A SYSTEM SCREW DURING A LUMBAR FUSION PROCEDURE, THE DISTAL TIP OF A SYSTEM SCREWDRIVER WAS BROKEN AND REQUESTED TO BE REPLACED. THERE WAS A MINIMAL DELAY IN TREATMENT AND NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR THE RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534945 ↗
• MalfunctionJul 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL THORACOLUMBAR POSTERIOR FIXATION PROCEDURE USING AN MIS APPROACH. DURING THE FINAL TIGHTENING STEP IN THE PROCEDURE, THE DISTAL TIP OF THE FINAL DRIVER FRACTURED OFF AND BECAME STUCK WITHIN THE MATING FEATURE OF THE SET SCREW. THE SURGEON UTILIZED A BURR TO REMOVE THE FRACTURED PIECE, RESULTING IN APPROXIMATELY A 2 HOUR SURGICAL DELAY. THE SET SCREW WAS REMOVED AND REPLACED WITH A NEW DEVICE AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660615 ↗
• MalfunctionJul 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL THORACOLUMBAR POSTERIOR FIXATION PROCEDURE USING AN MIS APPROACH. DURING THE FINAL TIGHTENING STEP IN THE PROCEDURE, THE DISTAL TIP OF THE FINAL DRIVER FRACTURED OFF AND BECAME STUCK WITHIN THE MATING FEATURE OF THE SET SCREW. THE SURGEON UTILIZED A BURR TO REMOVE THE FRACTURED PIECE, RESULTING IN APPROXIMATELY A 2 HOUR SURGICAL DELAY. THE SET SCREW WAS REMOVED AND REPLACED WITH A NEW DEVICE AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660600 ↗
• MalfunctionDec 5, 2018Break; Break

  IT WAS REPORTED THAT THE FINAL DRIVER TIP BROKE WHEN THE SURGEON WAS TRYING TO REMOVE A SET SCREW TO RETRIEVE A DISASSOCIATED PEDICLE SCREW. THE TIP OF THE DRIVER BROKE AND IS IMPLANTED IN THE SCREW IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY AND WITH NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8134609 ↗
• MalfunctionJun 30, 2017Break; Break

  DURING A POSTERIOR SPINAL FUSION SURGERY, THE TIP OF THE SCREW DRIVER BROKE OFF IN THE PATIENT. THE TIP WAS UNABLE TO BE RETRIEVED AND REMAINS IN THE PATIENT. SURGERY WAS COMPLETED WITHOUT INCIDENT AND THERE WAS NO REPORTED AFFECT ON THE PATIENT CAUSED BY THE IMPLANTED SCREW DRIVER TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6681719 ↗