CSLP 450.116Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034780504), received between May 10, 2021 and May 10, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 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.

• InjuryMay 10, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION SURGERY FOR A BROKEN PLATE. ON (B)(6) 2020, DUE TO A TRAUMATIC INJURY, THE PATIENT HAD AN ANTERIOR CERVICAL FUSION AT C5-C6 USING A CSLP PLATE. DURING A ROUTINE FOLLOW-UP VISIT ON (B)(6) 2021, THE SURGEON DISCOVERED THAT THE PLATE HAD BROKEN WHEN VIEWING ON A STANDARD FOLLOW-UP X-RAY. THE SURGEON PERFORMED THE REVISION SURGERY ON (B)(6) 2021. THE SURGEON CONFIRMED THAT THE PATIENT HAS A NON-UNION AT THE C5-C6 LEVEL. DURING THE REVISION, HE REMOVED THE BROKEN CSLP PLATE. THE EXPANSION HEAD SCREWS AND LOCKING SCREWS WERE ALSO COMPLETELY REMOVED AND NO FRAGMENTS/PARTS REMAIN IN THE PATIENT. ONE THE ENTIRE CSLP CONSTRUCT WAS REMOVED. THE SURGEON FLIPPED THAT PATIENT PRONE AND DID A C5-C6 POSTERIOR CERVICAL FUSION USING THE DEPUY SYNTHES SPINE SYMPHONY SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) TI CERVICAL SPINE LOCKING PLATE 24MM (16MM). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11797332 ↗