PSS System 00-9002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840019925594), received between Oct 14, 2021 and Oct 14, 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

Recent adverse event reports

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

• InjuryOct 14, 2021Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION PROCEDURE TO REMOVE AND REPLACE ANOTHER COMPANY'S PRODUCT WAS PERFORMED ON (B)(6), 2021, UTILIZING THE S-LOK POSTERIOR LUMBAR PEDICLE SCREW SYSTEM. DURING THE PROCEDURE ALL THE PEDICLE SCREWS HAD BEEN PLACED, TABS BROKEN OFF AND LOCKING CAPS WERE BEING INSERTED AND FINAL TIGHTENED. WHEN ATTEMPTING TO FINAL TIGHTEN THE LAST LOCK SCREW IT CROSS THREADED AND STRIPPED. THE PEDICLE SCREW THEN HAD TO BE REMOVED DUE TO DAMAGE TO THE TULIP THREADS AND UPON ATTEMPTED REMOVAL, THE TIP OF THE POLYAXIAL SCREWDRIVER LOCKING (00-9002) BROKE OFF. THE HEAD OF THE SCREW WAS THEN CUT OFF AND THE SCREW SHANK WAS REMOVED SUCCESSFULLY. ANOTHER SCREW WAS PLACED WITHOUT FURTHER ISSUE UTILIZING THE SECOND DRIVER READILY AVAILABLE IN THE SET. THERE WAS A DELAY OF TWENTY (20) MINUTES BECAUSE OF THE BROKEN DRIVER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12636264 ↗