General Instruments 5599130Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00763000583750), received between May 6, 2024 and Sep 30, 2026 — classified as 22 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, 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 ↗
• 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 ↗
• 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 24541710 ↗
• MalfunctionFeb 25, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING AN INSERTER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WOULD NO LONGER PROVISIONALLY HOLD THE SCREW HEAD, THE TULIP FELL OFF AND WOULD NOT SELF RETAIN, AND THE INSTRUMENT WAS NO LONGER ABLE TO BE USED IN SURGERY. 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 24440360 ↗
• MalfunctionJan 5, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT INSERTER CRIMPER NOT UNLOCKING. 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 23954617 ↗
• MalfunctionDec 24, 2025Degraded; Mechanical Problem; Degraded; Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICES WERE WORN. THE HANDLES DID NOT CRIMP OR HOLD THE HEAD ANYMORE, INSERTER HAD DULL THREADS, EXTRACTOR WAS WORN, HEAD INSERTER WAS NOT LOCKING, DRIVER HAD A SET SCREW THAT WAS NOT HOLDING, ADAPTER WAS NOT LOCKING, AND REDUCER WAS NOT LOCKING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886193 ↗
• MalfunctionDec 22, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE LOCKING IS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861982 ↗
• MalfunctionDec 16, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WON¿T HOLD THE HEAD PART IN PLACE. 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 23815655 ↗
• MalfunctionSep 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENT WAS MISSING A PIN WHICH IS NECESSARY FOR PROPER FUNCTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093790 ↗
• MalfunctionMay 6, 2024Mechanics Altered; Mechanics Altered

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE STATES, PROCEDURE OR TECHNIQUE PERFORMED WAS LAMINECTOMY/DECOMPRESS ION/TRANSFORAMINAL LUMBAR INTERBODY FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256475 ↗