Zodiac 62055-45Recalls & reported problems
Alphatec Spine, Inc. · TI STANDARD POLYAXIAL SCREW ASSY, 5.5MM x 45MM · Class 2 · Implant
All models of Zodiac (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 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 00844856002944), received between May 14, 2020 and Nov 18, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break2
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
Patient problems
- Pain2
- Numbness1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2020Break; Fracture
ONE YEAR AND 4 MONTHS AFTER THE INITIAL SURGERY, POST-OP X-RAYS FOUND THAT BOTH L5 SCREWS (RIGHT/LEFT) HAD FRACTURED & BROKE. THE PATIENT IS REPORTED TO HAVE LOWER LIMBS NUMBNESS AND LOW BACK PAIN. REVISION SURGERY SCHEDULE FOR EARLY (B)(6). (B)(6) 2019: INITIAL SURGERY WAS CONDUCTED. PLIF (ZODIAC DEGENERATIVE FIXATION SYSTEM AND ANOTHER MANUFACTURER'S SPACER).
Patient problems: Numbness; Pain
MAUDE report 10861726 ↗InjuryMay 14, 2020Break; Appropriate Device Problem Term/Code Not Available
ALPHATEC LEGAL RECEIVED A PRODUCT LIABILITY CLAIM ON APRIL 15, 2020. THE CLAIM ALLEGES THAT A PATIENT WHOM PREVIOUSLY HAD ATEC HARDWARE INSTALLED ((B)(6) 2018) STARTED TO EXPERIENCE PAIN ((B)(6) 2018). ON (B)(6) 2019, THE SURGEON DETERMINED SHE HAD BROKEN SCREWS AND OR HARDWARE IN HER L4 VERTEBRAE AND REVISION SURGERY WAS NECESSARY TO REMOVE AND REPLACE. THE REVISION TOOK PLACE ON (B)(6) 2019.
Patient problems: Pain
MAUDE report 10055894 ↗
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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