Reform Pedicle Screw System 39-PA-1050Recalls & reported problems
Precision Spine, Inc. · ø10.5 x 50 mm POLYAXIAL SCREW · Class 2 · Implant
All models of Reform Pedicle Screw System (11)
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 00815362028957), received between Apr 18, 2022 and Apr 18, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2022Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, TO ADDRESS A BROKEN REFORM PEDICLE SCREW, ATTRIBUTED TO NON-FUSION. THE ORIGINAL IMPLANTATION DATE WAS NOT PROVIDED. THE EXISTING CONSTRUCT WAS REMOVED AND UPON ATTEMPTED INSERTION OF A OF A REFORM 10.5 X 50MM POLYAXIAL PEDICLE SCREW (39-PA-1050) IN A NEWLY PREPARED PEDICLE, THE TIP OF THE REFORM POLYAXIAL DRIVER ((B)(4)) BROKE OFF IN THE HEAD OF THE SCREW. THE SCREW WAS THEN REMOVED AND SUCCESSFULLY REPLACED WITH ANOTHER SCREW USING A SECOND DRIVER IN THE SET. SUBSEQUENTLY, WHILE IMPLANTING ANOTHER REFORM 10.5 X 50MM POLYAXIAL PEDICLE SCREW (39-PA-1050) THE SCREW WAS 85% SEATED WHEN THE HEAD OF THE SCREW SHEARED OFF AT THE NECK BETWEEN THE SCREW HEAD AND THREADED SHAFT. THE THREADED SHAFT WAS LEFT IN THE PATIENT'S BONE AND THE PEDICLE WAS LEFT UN-FIXATED. THE CONSTRUCT WAS SUCCESSFULLY COMPLETED WITH NO HARM TO THE PATIENT. THERE WAS A DELAY OF ONE HOUR BECAUSE OF THE REPORTED MALFUNCTIONS.
Patient problems: Foreign Body In Patient
MAUDE report 14138139 ↗
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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