Instinct™ Java® System 046W0AN25545Recalls & reported problems
Zimmer Spine · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024340237), received between Oct 21, 2021 and Oct 21, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture3
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Pain3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.