General InstrumentsRecalls & reported problems across all models

We found 3 models of General Instruments by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between May 6, 2024 and Sep 30, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported General Instruments problems

General Instruments models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• General Instruments 5599130

  Orthopedic manual surgical instrument
  22 reports
• General Instruments 5597550

  Orthopedic manual surgical instrument
  1 report
• General Instruments 5597185

  SCREWDRIVER
  1 report

Recent General Instruments adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947429 ↗
• MalfunctionSep 25, 2026Mechanical Problem

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a device used for Spinal therapy. It was reported that the crimpers do not hold the head any longer. There was no patient involvement reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896686 ↗
• MalfunctionJul 29, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50065007 ↗
• MalfunctionJun 14, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENT WOULDN'T FULLY OPEN WHEN THE UNLOCK BLUE BUTTON WAS PRESSED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25497905 ↗
• MalfunctionJun 9, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE THREADS ON THE SHAFT SIDE ARE CRUSHED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25452470 ↗
• MalfunctionApr 20, 2026Mechanical Problem

  INFORMATION WAS OBTAINED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING INSERTERS USED FOR SPINAL THERAPY. IT WAS STATED THAT NEITHER OF THE HEAD INSERTERS WOULD APPROPRIATELY SQUEEZE TO PICK UP A TULIP HEAD. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE EVENT OCCURRED INTRA-OPERATIVELY WHEN THE PATIENT WAS AT BACK TABLE (INITIAL SETUP). THE PROCEDURE BEING PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24923047 ↗
• MalfunctionApr 20, 2026Mechanical Problem

  INFORMATION WAS OBTAINED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING INSERTERS USED FOR SPINAL THERAPY. IT WAS STATED THAT NEITHER OF THE HEAD INSERTERS WOULD APPROPRIATELY SQUEEZE TO PICK UP A TULIP HEAD. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE EVENT OCCURRED INTRA-OPERATIVELY WHEN THE PATIENT WAS AT BACK TABLE (INITIAL SETUP). THE PROCEDURE BEING PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24923040 ↗
• MalfunctionMar 13, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE INSERTER BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597474 ↗
• MalfunctionMar 11, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT WHILE PULLING BACK TO CHECK INSERTION, LOCKER DISENGAGED PREMATURELY. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566605 ↗
• MalfunctionMar 11, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT WHILE PULLING BACK TO CHECK INSERTION, LOCKER DISENGAGED PREMATURELY. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566596 ↗
• MalfunctionMar 10, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY PROCEDURE. IT WAS REPORTED THAT THE CRIMPER WAS NOT CRIMPING HEADS TO SHANKS PROPERLY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555128 ↗
• MalfunctionMar 10, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY PROCEDURE. IT WAS REPORTED THAT THE CRIMPER WAS NOT CRIMPING HEADS TO SHANKS PROPERLY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555111 ↗
• MalfunctionMar 10, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY PROCEDURE. IT WAS REPORTED THAT THE CRIMPER WAS NOT CRIMPING HEADS TO SHANKS PROPERLY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555104 ↗
• MalfunctionMar 10, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY PROCEDURE. IT WAS REPORTED THAT THE CRIMPER WAS NOT CRIMPING HEADS TO SHANKS PROPERLY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555101 ↗
• MalfunctionMar 8, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE INSERTER COULD NOT HOLD THE MODULEX HEADS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541712 ↗

Other Medtronic Sofamor Danek, Inc. products

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