NA 214.538Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982154156), received between Nov 17, 2020 and Dec 13, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2021Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5104701, A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE SCREW CAUGHT AN END OF THE CORTEX AND SPIRALED A SMALL FRAGMENT OFF THE SCREW. THE SMALL FRAGMENT WAS RETAINED. THERE WAS AN UNKNOWN SURGICAL DELAY. IT WAS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND IF THERE WAS ANY PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12986377 ↗
• MalfunctionNov 17, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING A CASE A 4.5MM CANNULATED SCREW PARTIALLY THREADED 38MM WAS ABOUT TO BE INSERTED INTO THE PATIENT WHEN IT WAS NOTICED THAT THE TIP OF THE SCREW WAS BROKEN. THE SCREW WAS NEVER INSERTED INTO THE PATIENT AND A REPLACEMENT WAS USED. THERE WAS NO HARM TO THE PATIENT OR SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 4.5MM CANNULATED SCREW PARTIALLY THREADED/38MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10854088 ↗
• MalfunctionNov 17, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING A CASE THE TIP OF A 4.5MM CANNULATED SCREW PARTIALLY THREADED 38MM WAS BROKEN. A REPLACEMENT SCREW WAS THEN USED. THE BROKEN SCREW WAS NOT INSERTED INTO THE PATIENT, THERE WAS NO HARM TO THE PATIENT OR DELAY IN THE CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 4.5MM CANNULATED SCREW PARTIALLY THREADED/38MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10852618 ↗