Zodiac 62085-45Recalls & reported problems
Alphatec Spine, Inc. · TI 8.5MM POLYAXIAL SCREW ASSY, 45mm · Class 2 · Implant
All models of Zodiac (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844856003248), received between Oct 4, 2016 and Oct 4, 2016 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 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 16, 2026.
Most reported problems
Device problems
- Fracture2
- Break1
- Component Falling1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2016Break; Fracture
FOLLOW UP X-RAYS TAKEN (B)(6) 2016 REVEALED THE POLYAXIAL SCREW LOCATED AT THE RIGHT L5 HAD FRACTURED AND BROKE. REVISION SURGERY IS SCHEDULED FOR (B)(6) 2016. THE ZODIAC DEGENERATIVE SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2015 FROM THE L3 TO L5.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5998183 ↗InjuryOct 4, 2016Component Falling; Fracture
POST OP X-RAYS TAKEN (B)(6) 2016 REVEALED TWO (2) POLYAXIAL SCREWS LOCATED AT L5 HAD FRACTURED AND BROKE. REVISION SURGERY WAS CONDUCTED (B)(6) 2016 TO REMOVE AND REPLACE THE ZODIAC CONSTRUCT. THE PROXIMAL SECTIONS OF BOTH SCREWS WERE REMOVED WITHOUT ISSUE, WHILE THE DISTAL THREADED PORTIONS REMAIN ENTRAPPED WITHIN THE RIGHT & LEFT SIDE OF THE PATIENTS L5. THE ZODIAC DEGENERATIVE SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2015 FROM THE L3 TO L5.
Patient problems: Device Embedded In Tissue or Plaque; No Code Available
MAUDE report 5998069 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page