PSS System SLP6535Recalls & reported problems
Precision Spine, Inc. · 6.5mm x 35mm 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 00840019913645), received between Oct 21, 2021 and Oct 21, 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
- Appropriate Device Problem Term/Code Not Available1
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2021Break; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL IMPLANTATION ON (B)(6) 2021, DURING WHICH SURELOK PEDICLE SCREW SYSTEM PRODUCT WAS IMPLANTED. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED IN (B)(6) ON (B)(6) 2021, TO ADDRESS A BROKEN 6.5MM X 35MM S-LOK POLYAXIAL SCREW (SLP6535). AS CONFIRMED BY THE SURGEON, FUSION WAS ACHIEVED AT THE TIME OF THE REVISION PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 12674412 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.