NA 03.161.057Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034711720), received between May 8, 2018 and Oct 25, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING SURGERY, A BROKEN TEMPORARY FIXATION PIN. IT WAS EASILY REMOVED WITH A DELAY OF 2 MINUTES. IT WAS REMOVED QUICKLY AND HAD NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533046 ↗
• InjuryApr 24, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE TEMP FIX PIN BROKE INSIDE THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A TEMPORARY FIXATION PIN. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16797387 ↗
• InjuryDec 21, 2022Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THE SURGEON WAS PUTTING A TEMPORARY FIXATION PIN TO THE RETRIEVAL BODY AND TEMPORAL FIXATION PIN BROKE. THE ITEM WAS TEMPORARY FIXATION PIN-LONG. THE ITEM LEFT IN RETRIEVAL BODY AND THE PARTS ABLE TO GET OUT STILL HAD COLLATION. NO COMPLICATION IN CASE AND THE PATIENT WAS DOING FINE. NO OTHER INFORMATION. THIS REPORT IS FOR ONE (1) TEMPORARY FIXATION PIN-LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16025063 ↗
• MalfunctionMay 8, 2018Break; Break

  IT WAS REPORTED THAT THE TEMPORARY FIXATION PIN WAS FOUND BROKEN IN A PAN ON AN UNKNOWN DATE. IT WAS ALSO REPORTED THAT THE PIECE OF THE TEMPORARY FIXATION PIN THAT BROKE OFF WAS DISCARDED AND THE BROKEN SHAFT WAS IMMEDIATELY TAKEN OUT OF USE. THERE WAS NO SURGICAL DELAY AND PATIENT INVOLVEMENT REPORTED. THERE WAS NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7494980 ↗
• InjuryMay 8, 2018Break; Break

  IT WAS REPORTED THAT DURING ANTERIOR SPINAL FUSION, THE PATIENT UNDERWENT REMOVAL OF THE TEMPORARY FIXATION PIN ON (B)(6) 2018. DURING THE REMOVAL, THE PIN BROKE OFF. THE SURGEON USED A VISE-GRIP PLIERS AND A SCREW REMOVAL BIT TO GRAB THE BROKEN PIN BUT THE SURGEON COULD NOT REMOVE IT FROM THE PATIENT. THE DEVICE WAS LEFT IN THE PATIENT. THE PLATE WAS SECURED USING ALL FOUR SCREWS WITH THE BROKEN TEMPORARY PIN LEFT IN THE VERTEBRAL BODY. PATIENT STATUS WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO OTHER ADDITIONAL INFORMATION PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7494934 ↗