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PSS System SLPL6540Recalls & reported problems

Precision Spine, Inc. · 6.5mm x 40mm SureLOK Polyaxial Screw Long Arm · 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 00840019914093), received between Feb 25, 2021 and Feb 25, 2021 — 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
  • Device Dislodged or Dislocated1

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.

  • InjuryFeb 25, 2021Break; Device Dislodged or Dislocated

    IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN THE (B)(6) ON (B)(6) 2021, UTILIZING THE SURELOK PSS PEDICLE SCREW SYSTEM. WHEN SETTING THE LOCK SCREW IN POSITION IT SLIPPED AND HAD NO LOCKING. CROSS THREADING HAPPENED. THE DAMAGED PEDICLE SCREW WAS REMOVED AND REPLACED WITH ANOTHER THAT WAS READILY AVAILABLE IN THE SET ALONG WITH A NEW LOCK SCREW. THE REPORTED ISSUE RESULTED IN A FIFTEEN (15) MINUTE DELAY TO THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11382077 ↗

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