ZodiacRecalls & reported problems across all models

We found 11 models of Zodiac by Alphatec Spine, Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Mar 31, 2016 and Dec 21, 2023 — classified as 12 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 Zodiac problems

Zodiac models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Zodiac 62979

  SCREWDRIVER
  7 reports
• Zodiac 22015

  ORTHOSIS, SPINAL PEDICLE FIXATION
  5 reports
• Zodiac 92939

  SCREWDRIVER
  4 reports
• Zodiac 62055-45

  ORTHOSIS, SPINAL PEDICLE FIXATION
  2 reports
• Zodiac 62085-45

  ORTHOSIS, SPINAL PEDICLE FIXATION
  2 reports
• Zodiac 62003-05

  Orthosis, spondylolisthesis spinal fixation
  1 report
• Zodiac 62065-40

  Orthosis, spondylolisthesis spinal fixation
  1 report
• Zodiac 62065-45

  ORTHOSIS, SPINAL PEDICLE FIXATION
  1 report
• Zodiac 62941

  SCREWDRIVER
  1 report
• Zodiac 22085

  Orthosis, spondylolisthesis spinal fixation
  1 report
• Zodiac 62005-60

  ORTHOSIS, SPINAL PEDICLE FIXATION
  1 report

Recent Zodiac adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Break; Break

  IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF WHILE REMOVING SCREWS. THE TIP WAS RETRIEVED AND DISCARDED AT THE HOSPITAL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373291 ↗
• MalfunctionApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT UNDERWENT POSTERIOR SPINAL FIXATION SURGERY ON AN UNKNOWN DATE IN 2012. ON (B)(6) 2023, A POSTOPERATIVE RADIOGRAPH REVEALED A SET SCREW HAD LOOSENED. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT. REVISION SURGERY IS NOT PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16801260 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 10, 2019Break; Fracture

  THE TIP OF THE DRIVER FRACTURED AND BROKE DURING USE.

  Patient problems: No Patient Involvement

  MAUDE report 9444697 ↗
• MalfunctionJul 17, 2019Device Dislodged or Dislocated

  SET SCREW BACK OUT FOUND AT L4 DURING A POST-OP VISIT CONDUCTED ON (B)(6) 2019. THE SURGEON HAS DECIDED NOT TO PERFORM REVISION SURGERY AT THIS TIME. THE ZODIAC SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2019 FROM THE T10 THRU L4.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8799605 ↗
• InjuryJun 7, 2019Break

  THE DISTAL TIP OF A POLYAXIAL SCREW REMOVER BROKE OFF DURING AN EXPLANT. THE DETACHED TIP REMAINS POSITIONED WITHIN THE HEAD OF THE POLYAXIAL SCREW, IMPLANTED WITHIN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8678560 ↗
• InjuryJan 3, 2019Improper or Incorrect Procedure or Method

  REVISION SURGERY WAS CONDUCTED ON (B)(6) 2018 TO REMOVE AND REPLACE THE SET SCREWS LOCATED AT THE L2/3/4. THE CONSTRUCT WAS ORIGINALLY IMPLANTED ON (B)(6) 2018 DURING A POSTERIOR LUMBER FUSION (PLF) OF THE L2/3/4. THE SURGEON SUSPECTS THEY MAY HAVE FORGOTTEN TO PERFORM THE FINAL TIGHTENING PROCESS.

  Patient problems: No Code Available

  MAUDE report 8212360 ↗
• MalfunctionNov 29, 2018Break; Fracture; Loose or Intermittent Connection

  SURGEON WAS INSTALLING CROSSLINK AND PART OF IT DIDN'T COMPLETELY LOCK. SURGEON UNLOCKED AND LOCKED ONCE AGAIN BUT PART OF IT WAS IN A WEIRD POSITION. DURING THIS TIME THE DISTAL TIP OF THE BRIDGE DRIVER FRACTURE AND BROKE. THE EVENT CAUSED NO PATIENT HARM. THE CASE WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116835 ↗
• InjurySep 5, 2018Disconnection

  THE DOCTOR FOUND THE DISCONNECTION OF TWO SET SCREWS TWO WEEKS AFTER THE INITIAL SURGERY. RE-OPERATION WAS CONDUCTED ON (B)(6) 2018 TO REPLACE AND TIGHTEN THE SET SCREWS. THE ILLICO MIS POSTERIOR FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2018.

  Patient problems: No Information

  MAUDE report 7845746 ↗
• MalfunctionJun 19, 2018Material Torqued; Material Twisted/Bent

  THE HEXALOBE PART COMPLETELY TWISTED AND OVER TORQUED. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Information

  MAUDE report 7613572 ↗
• InjuryMay 16, 2017Fracture

  AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT REVISION SURGERY WAS CONDUCTED ON (B)(6) 2017 TO REMOVE A ZODIAC ROD WHICH HAD FRACTURED AND BROKE.

  Patient problems: Failure of Implant

  MAUDE report 6570700 ↗
• MalfunctionMar 7, 2017Break

  TIP OF THE DRIVER WAS FOUND BROKEN DURING ROUTINE INSPECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6385774 ↗
• InjuryDec 7, 2016Loose or Intermittent Connection; Malposition of Device

  AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED REVISION SURGERY WAS CONDUCTED ON (B)(6) 2016 TO REMOVE AND REPLACE THE SET SCREW LOCATED ON LEFT SIDE OF THE ILIAC. THE SET SCREW ORIGINALLY IMPLANTED ON (B)(6) 2015 WAS FOUND TO HAVE BACKED OUT OF POSITION. DURING THE SURGERY, IT WAS NOTICED THAT THE ILIAC PEDICLE SCREW ALSO APPEARED TO BE LOOSE. BOTH THE ILIAC PEDICLE SCREW AND SET SCREW WERE REPLACED IN ADDITION TO THE EXPANSION OF THE ORIGINAL CONSTRUCT. X-RAYS TAKEN DURING THE (B)(6) 2016 POST-OP VISIT REVEALED THAT THE SET SCREW LOCATED ON LEFT SIDE OF THE ILIAC HAD ONCE AGAIN BACKED OUT OF POSITION. REVISION TO REMOVE AND REPLACE THE SET SCREW WAS CONDUCTED ON (B)(6) 2016.

  Patient problems: Foreign Body In Patient

  MAUDE report 6151958 ↗

Other Alphatec Spine, Inc. products

• Invictus96 models · 448 reports
• IdentiTi31 models · 68 reports · 1 recall
• ATEC Lateral Navigation Disc Prep Instruments2 models · 0 reports · 2 recalls
• Calibrate44 models · 40 reports · 1 recall
• Arsenal18 models · 86 reports
• Illico20 models · 69 reports
• AMP5 models · 4 reports · 1 recall
• Insignia34 models · 54 reports