Zodiac 22015Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844856043688), received between Dec 7, 2016 and Apr 24, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗