Instinct Java SystemRecalls & reported problems across all models
Zimmer Spine · 7 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 7 models of Instinct Java System by Zimmer Spine in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Nov 7, 2019 and Aug 29, 2022 — classified as 5 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Fracture” (34 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 Instinct Java System problems
Device problems
- Fracture34
- Material Deformation4
- Material Twisted/Bent3
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Consequences Or Impact To Patient8
- No Known Impact Or Consequence To Patient5
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Pain3
- Foreign Body In Patient2
Instinct Java System models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Instinct® Java™ System 046W1AN00641Orthosis, spinal pedicle fixation, for degenerative disc disease29 reports
- Instinct® Java™ System 046W1AN00640ORTHOSIS, SPINAL PEDICLE FIXATION4 reports
- Instinct™ Java® System 046W0AN25545ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
- Instinct™ Java® System 046W0AN26540Orthosis, spondylolisthesis spinal fixation1 report
- Instinct™ Java® System 046W0AN26545ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Instinct™ Java® System 046W0AN46540Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- Instinct™ Java® System 046W0AN65545Orthosis, spondylolisthesis spinal fixation1 report
Recent Instinct Java System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2022Fracture; Fracture
IT WAS REPORTED THAT A WAREHOUSE FOUND TWO FINAL DRIVERS BOTH WITH FRACTURED TIPS DURING INSPECTION AFTER THEY WERE RETURNED FROM A HOSPITAL. THE HOSPITAL DID NOT PROVIDE ANY PATIENT OR SURGICAL INFORMATION WITH THE RETURNED DEVICES. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 15310887 ↗MalfunctionAug 29, 2022Fracture; Fracture
IT WAS REPORTED THAT A WAREHOUSE FOUND TWO FINAL DRIVERS BOTH WITH FRACTURED TIPS DURING INSPECTION AFTER THEY WERE RETURNED FROM A HOSPITAL. THE HOSPITAL DID NOT PROVIDE ANY PATIENT OR SURGICAL INFORMATION WITH THE RETURNED DEVICES. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 15310867 ↗MalfunctionMay 16, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TIPS OF THREE INSTINCT JAVA SCREWDRIVERS BROKE ON THREE DIFFERENT CLOSURE TOPS DURING FINAL TIGHTENING INTRA-OPERATIVELY. ONE OF THE BROKEN TIPS OF THE SCREWDRIVER COULD NOT BE REMOVED FROM THE CLOSURE TOP AND REMAINS IMPLANTED. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14407733 ↗InjuryMay 16, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TIPS OF THREE INSTINCT JAVA SCREWDRIVERS BROKE ON THREE DIFFERENT CLOSURE TOPS DURING FINAL TIGHTENING INTRA-OPERATIVELY. ONE OF THE BROKEN TIPS OF THE SCREWDRIVER COULD NOT BE REMOVED FROM THE CLOSURE TOP AND REMAINS IMPLANTED. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 14407708 ↗MalfunctionApr 22, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING THE SURGERY, A FINAL DRIVER STRIPPED. HOWEVER, DEVICE EVALUATION BY THE MANUFACTURER FOUND THE TIP HAD FRACTURED OFF. A SECOND DRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14186856 ↗MalfunctionMar 8, 2022Fracture; Fracture
IT WAS REPORTED THAT ONE INSTINCT FINAL DRIVER WAS RETURNED FROM A HOSPITAL WITH THE TIP FRACTURED OFF; THE TIP WAS NOT RETURNED. THE SPECIFIC SURGICAL OR PATIENT INFORMATION IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 13686237 ↗MalfunctionNov 17, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIPS OF THREE FINAL DRIVERS BROKE OFF IN A BLOCKER INTRA-OPERATIVELY. THE TIPS WERE RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER FINAL DRIVER. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12828298 ↗MalfunctionNov 17, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIPS OF THREE FINAL DRIVERS BROKE OFF IN A BLOCKER INTRA-OPERATIVELY. THE TIPS WERE RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER FINAL DRIVER. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12828281 ↗MalfunctionNov 17, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIPS OF THREE FINAL DRIVERS BROKE OFF IN A BLOCKER INTRA-OPERATIVELY. THE TIPS WERE RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER FINAL DRIVER. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12828279 ↗MalfunctionNov 7, 2021Fracture; Fracture
IT WAS REPORTED THE TIPS OF TWO FINAL SCREWDRIVER SHAFTS BROKE INTRA-OPERATIVELY WHILE FINAL TIGHTENING THE BLOCKERS. THE FRAGMENTS WERE RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER FINAL DRIVER SHAFT WITHOUT PATIENT IMPACTS. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12761629 ↗MalfunctionNov 7, 2021Fracture; Fracture
IT WAS REPORTED THE TIPS OF TWO FINAL SCREWDRIVER SHAFTS BROKE INTRA-OPERATIVELY WHILE FINAL TIGHTENING THE BLOCKERS. THE FRAGMENTS WERE RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER FINAL DRIVER SHAFT WITHOUT PATIENT IMPACTS. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12761612 ↗MalfunctionNov 7, 2021Fracture; Fracture
IT WAS REPORTED THE TIPS OF TWO FINAL SCREWDRIVER SHAFTS BROKE INTRA-OPERATIVELY WHILE FINAL TIGHTENING THE BLOCKERS. THE FRAGMENTS WERE RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER FINAL DRIVER SHAFT WITHOUT PATIENT IMPACTS. THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12761532 ↗InjuryOct 21, 2021Fracture; Fracture
IT WAS REPORTED A REVISION SURGERY WAS PERFORMED TO ADDRESS 3 INSTINCT JAVA SCREWS THAT FRACTURED POST-OPERATIVELY. THEY WERE DISCOVERED AFTER THE PATIENT PRESENTED WITH PAIN. A CT SCAN SHOWED METALLOSIS DEVELOPED AROUND THE SCREWS IN ADDITION TO THE BREAKAGE. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 12672158 ↗InjuryOct 21, 2021Fracture; Fracture
IT WAS REPORTED A REVISION SURGERY WAS PERFORMED TO ADDRESS 3 INSTINCT JAVA SCREWS THAT FRACTURED POST-OPERATIVELY. THEY WERE DISCOVERED AFTER THE PATIENT PRESENTED WITH PAIN. A CT SCAN SHOWED METALLOSIS DEVELOPED AROUND THE SCREWS IN ADDITION TO THE BREAKAGE. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 12672123 ↗InjuryOct 21, 2021Fracture; Fracture
IT WAS REPORTED A REVISION SURGERY WAS PERFORMED TO ADDRESS 3 INSTINCT JAVA SCREWS THAT FRACTURED POST-OPERATIVELY. THEY WERE DISCOVERED AFTER THE PATIENT PRESENTED WITH PAIN. A CT SCAN SHOWED METALLOSIS DEVELOPED AROUND THE SCREWS IN ADDITION TO THE BREAKAGE. THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 12672114 ↗
Other Zimmer Spine products
All Zimmer Spine devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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