NA 03.616.035Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034716275), received between Mar 21, 2023 and Mar 21, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 THE REDUCTION MIS BLADES WAS HAVING DIFFICULTY IN ATTACHING, IT WAS HOLD ONTO THE HEAD OF THE SCREW AND REMAIN ATTACHED. THERE WAS SPECULATED CONCERN ABOUT SIGNIFICANT WEAR TO THE SPRING CLIP MECHANISM. THERE WAS NO SURGICAL DELAY AND NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) TISSUE RETRACTOR-CENTER. THIS IS REPORT 5 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582189 ↗
• MalfunctionMar 21, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 THE REDUCTION MIS BLADES WAS HAVING DIFFICULTY IN ATTACHING, IT WAS HOLD ONTO THE HEAD OF THE SCREW AND REMAIN ATTACHED. THERE WAS SPECULATED CONCERN ABOUT SIGNIFICANT WEAR TO THE SPRING CLIP MECHANISM. THERE WAS NO SURGICAL DELAY AND NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) TISSUE RETRACTOR-CENTER. THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582185 ↗
• MalfunctionMar 21, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 THE REDUCTION MIS BLADES WAS HAVING DIFFICULTY IN ATTACHING, IT WAS HOLD ONTO THE HEAD OF THE SCREW AND REMAIN ATTACHED. THERE WAS SPECULATED CONCERN ABOUT SIGNIFICANT WEAR TO THE SPRING CLIP MECHANISM. THERE WAS NO SURGICAL DELAY AND NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) TISSUE RETRACTOR-CENTER. THIS IS REPORT 2 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582181 ↗
• MalfunctionMar 21, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 THE REDUCTION MIS BLADES WAS HAVING DIFFICULTY IN ATTACHING, IT WAS HOLD ONTO THE HEAD OF THE SCREW AND REMAIN ATTACHED. THERE WAS SPECULATED CONCERN ABOUT SIGNIFICANT WEAR TO THE SPRING CLIP MECHANISM. THERE WAS NO SURGICAL DELAY AND NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) TISSUE RETRACTOR-CENTER. THIS IS REPORT 4 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582174 ↗
• MalfunctionMar 21, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 THE REDUCTION MIS BLADES WAS HAVING DIFFICULTY IN ATTACHING, IT WAS HOLD ONTO THE HEAD OF THE SCREW AND REMAIN ATTACHED. THERE WAS SPECULATED CONCERN ABOUT SIGNIFICANT WEAR TO THE SPRING CLIP MECHANISM. THERE WAS NO SURGICAL DELAY AND NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) TISSUE RETRACTOR-CENTER. THIS IS REPORT 8 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582172 ↗
• MalfunctionMar 21, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 THE REDUCTION MIS BLADES WAS HAVING DIFFICULTY IN ATTACHING, IT WAS HOLD ONTO THE HEAD OF THE SCREW AND REMAIN ATTACHED. THERE WAS SPECULATED CONCERN ABOUT SIGNIFICANT WEAR TO THE SPRING CLIP MECHANISM. THERE WAS NO SURGICAL DELAY AND NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) TISSUE RETRACTOR-CENTER. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582170 ↗
• MalfunctionMar 21, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 THE REDUCTION MIS BLADES WAS HAVING DIFFICULTY IN ATTACHING, IT WAS HOLD ONTO THE HEAD OF THE SCREW AND REMAIN ATTACHED. THERE WAS SPECULATED CONCERN ABOUT SIGNIFICANT WEAR TO THE SPRING CLIP MECHANISM. THERE WAS NO SURGICAL DELAY AND NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) TISSUE RETRACTOR-CENTER. THIS IS REPORT 7 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582167 ↗
• MalfunctionMar 21, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 THE REDUCTION MIS BLADES WAS HAVING DIFFICULTY IN ATTACHING, IT WAS HOLD ONTO THE HEAD OF THE SCREW AND REMAIN ATTACHED. THERE WAS SPECULATED CONCERN ABOUT SIGNIFICANT WEAR TO THE SPRING CLIP MECHANISM. THERE WAS NO SURGICAL DELAY AND NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) TISSUE RETRACTOR-CENTER. THIS IS REPORT 3 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582138 ↗