S-LOK PSS System 43-TL-6545Recalls & reported problems
Precision Spine, Inc. · Ø6.5 MD-Max™ Triple Lead Screw 45mm · 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 00840019915229), received between Mar 14, 2023 and Mar 14, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2023Physical Resistance/Sticking
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN JORDAN, UTILIZING THE MD MAX ULIF SYSTEM. DURING INSERTION THE MD-MAX TRIPLE LEAD POLYAXIAL SCREW ASSEMBLY 6.5 X 45MM (43-TL-6545) WAS STUCK WITH NO WAY TO MOVE IT IN OR OUT. THE SCREW WAS ULTIMATELY REMOVED BY FORCE, ONCE THE INCISION WAS OPENED FURTHER. THE SURGEON CHOSE NOT TO ATTEMPT TO IMPLANT ANOTHER SCREW IN THIS VERTEBRAE. THERE WAS A DELAY TO THE PROCEDURE, BUT UNKNOWN HOW LONG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16541874 ↗
Other Orthosis, Spinal Pedicle Fixation devices
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- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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