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PSS System SLP4540Recalls & reported problems

Precision Spine, Inc. · 4.5mm x 40mm SureLOK Polyaxial Screw · Class 2 · Implant

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 00840019913492), received between Feb 10, 2020 and Feb 10, 2020 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Failure of Implant1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 10, 2020Break

    IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2019 UTILIZING THE SURELOK PEDICAL SCREW SYSTEM. DURING THE PROCEDURE AN AWL WAS USED TO PREPARE THE PATIENT'S BONE AND UPON ATTEMPTED INSERTION OF A 4.5MM X 40MM S-LOK POLYAXIAL SCREW (SLP4540), THE SCREW BROKE MID-SHAFT. ALL PIECES OF THE SCREW WERE EASILY REMOVED, THE BONE WAS THEN TAPPED AND A LARGER DIAMETER, 6.5MM X 40MM S-LOK POLYAXIAL SCREW WAS SUCCESSFULLY IMPLANTED. IT WAS NOTED THAT THE PATIENT HAD EXTREMELY HARD BONE. THERE WAS NO DELAY TO THE PROCEDURE OR PATIENT INJURY. THE SURGEON ATTRIBUTED THE SCREW BREAKAGE TO THE PATIENT'S HARD BONE.

    Patient problems: Failure of Implant

    MAUDE report 9687622 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.