Spectra-System®/ Legacy™ Guided Surgery Handle Kit G-HKRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10841307119210), received between Jun 9, 2017 and Dec 1, 2021 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2021Osseointegration Problem; Osseointegration Problem

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, DEFORMATION WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 12909083 ↗
• MalfunctionMar 11, 2021Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, GUIDED SURGICAL KITS AND INSERTS ARE BINDING.

  Patient problems: Failure of Implant

  MAUDE report 11458466 ↗
• InjuryDec 29, 2020Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 11087759 ↗
• MalfunctionFeb 19, 2020Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), SURGICAL GUIDE HANDLE IS APPARENTLY WARPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9725527 ↗
• InjuryNov 20, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), COMPONENT WAS FRACTURED OR BROKEN AND COULD NOT BE SEPARATED.

  Patient problems: Failure of Implant; No Information

  MAUDE report 9346769 ↗
• MalfunctionNov 6, 2019Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE IT WAS OBSERVED THAT THE COMPONENTS COULD NOT BE SEPARATED.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 9283253 ↗
• MalfunctionJun 13, 2019Material Separation; Material Separation

  PER COMPLAINT (B)(4), A G-SLEEVE INSTRUMENT RING POPPED OUT WHILE DRILLING A PATIENT'S BONE FOR DENTAL IMPLANT PLACEMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE PROCEDURE WAS COMPLETED WITHIN THE SAME VISIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696587 ↗
• InjuryNov 1, 2017Device-Device Incompatibility; Device-Device Incompatibility

  DRILLS BECAME STUCK IN THE GUIDED HANDLES DURING SURGICAL PROCEDURE. THIS CAUSED THE OSTEOTOMY TO BE INACCURATELY DRILLS AND THE IMPLANT SPUN DUE TO OVER "PREPERATION" CAUSE BY THE GUIDED HANDLE MALFUNCTION.

  Patient problems: No Information

  MAUDE report 6995239 ↗
• MalfunctionJun 9, 2017Nonstandard Device; Failure to Advance

  THE 2.3 GUIDE INSERT WILL NOT ALLOW THE 2.3 DRILL TO PASS THROUGH, THE DIAMETER IS TOO SMALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6632595 ↗