Zodiac 62065-45Recalls & reported problems
Alphatec Spine, Inc. · TI STANDARD POLYAXIAL SCREW ASSY, 6.5MM x 45MM · Class 2 · Implant
All models of Zodiac (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844856003026), received between Aug 10, 2021 and Aug 10, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
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
- Loose or Intermittent Connection1
Patient problems
- Pain1
- Unspecified Infection1
- Weight Changes1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
ON (B)(6) 2021, A FEMALE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING OF THE L3 SCREW. IT WAS REPORTED THIS WAS A RESULT OF WEIGHT REDUCTION CAUSED BY COLLAGEN DISEASE, PAIN, AND (B)(6). WHILE REMOVING THE SCREW THE SURGEON COULD NOT UNLOCK THE SCREW HEAD. HE WAS ABLE TO REMOVE THE SCREW IN THE LOCK POSITION DUE TO THE LOOSENING.
Patient problems: Pain; Unspecified Infection; Weight Changes
MAUDE report 12304930 ↗
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.
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