NA 03.615.042Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034715353), received between Oct 26, 2018 and Oct 26, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2018, A PERSUADER CAME APART FROM THE HANDLE DURING A POSTERIOR SPINAL FUSION, PERSUADER MOUTH PLUNGED INTO INCISION SITE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. SURGERY AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR (1) PERSUADER. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: Paralysis

  MAUDE report 8010205 ↗
• InjuryOct 26, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2018, A PERSUADER CAME APART FROM THE HANDLE DURING A POSTERIOR SPINAL FUSION, PERSUADER MOUTH PLUNGED INTO INCISION SITE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. SURGERY AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR (1) LOCKING PERSUADER HANDLE. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Paralysis

  MAUDE report 8010202 ↗