Reform Ti Modular 39-SK-6550Recalls & reported problems
Precision Spine, Inc. · Ø6.5 x 50mm Modular Bone Screw, Cannulated · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840019933636), received between Oct 20, 2023 and Oct 20, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Inadequate Pain Relief1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL L5/S1 IMPLANTATION OF MODULAR CANNULATED SCREWS O (B)(6) 2023, IN AUSTRALIA. SUBSEQUENTLY, THE PATIENT PRESENTED WITH PAIN, AND IT WAS IDENTIFIED THAT THE SCREWS IN S1 HAD BROKEN. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2023, DURING WHICH IT WAS NOTED THAT LEFT S1 WAS BROKEN MID-SHAFT (DISTAL TO THE DIAMETER TRANSITION). THE PROXIMAL END OF 39-SK-6550 WAS EXPLANTED, THE DISTAL FRAGMENT REMAINS IN THE PATIENT. A 39-SK-7580 SHANK (WITH TULIP AND SET SCREW) WERE IMPLANTED AT THE ILIAC CREST FOR ADDITIONAL STRENGTH AND TO AVOID THE FRAGMENT. THE PROXIMAL END OF 39-SK-6545 WAS EXPLANTED AND THE DISTAL FRAGMENT REMAINS IN THE PATIENT. A 39-SK-7570 SHANK (WITH TULIP AND SET SCREW) WERE IMPLANTED AT THE ILIAC CREST ON THE RIGHT SIDE FOR ADDITIONAL STRENGTH AND TO AVOID THE FRAGMENT. THE L5 SCREWS WERE REMOVED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 17976975 ↗
Other Thoracolumbosacral Pedicle Screw System devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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