Illico 73772Recalls & reported problems
Alphatec Spine, Inc. · REDUCTION SCREW EXTENDER · Class 1
Quick summary
This Alphatec Spine reduction screw extender is a surgical instrument used to help reposition and tighten a spinal screw during surgery. The reports mostly describe the tool's tabs or wings snapping off mid-operation, sometimes leaving small metal fragments in the patient and forcing the surgeon to replace the screw. There are 34 reports, with 3 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00840967192901), received between Mar 7, 2016 and Dec 9, 2020 — classified as 3 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Break” (32 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break32
- Detachment of Device or Device Component1
- Difficult to Remove1
- Entrapment of Device1
- Failure to Advance1
- Physical Resistance/Sticking1
Patient problems
- No Known Impact Or Consequence To Patient23
- No Information9
- Complaint, Ill-Defined1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjuryDec 9, 2020Break; Physical Resistance/Sticking
DURING THE SURGERY, THE SURGEON PERFORMED THE REDUCTION OF THE SCREW WITH STRENGTH, BECAUSE IT WAS DIFFICULT TO MOVE THE REDUCER WHEN REDUCTION OF THE L4 SCREW LEFT SIDE. THEN THE TIP PART (JOINTED PARTS WITH THE SCREW) OF THE REDUCTION EXTENDER WAS BROKEN. AS THE RESULT, IT WAS NECESSARY TO REPLACE THE SCREW DUE TO THE BREAKAGE OF THE INSTRUMENT. WHEN REPLACING THE SCREW, THE REDUCER DID NOT MOVE SMOOTHLY ONCE AGAIN, BUT THE SET SCREW ENGAGED SLIGHTLY AND THE SURGEON CONTINUED THE FIXATION WITHOUT ANY EXTRA REDUCTION. THE SURGERY WAS COMPLETED WITH ONE-HOUR DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10977212 ↗MalfunctionFeb 20, 2020Detachment of Device or Device Component
ONE OF THE TABS BROKE OFF THE SCREW EXTENDER WHILE REDUCING THE ROD. THE DETACHED SECTION WAS REMOVED FROM THE PATIENT WITHOUT ISSUE AND THE ROD FULLY REDUCED WITH NO FURTHER COMPLICATION. THE EVENT CAUSE NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9732174 ↗MalfunctionOct 31, 2019Break
ONE OF THE TABS BROKE OFF THE SCREW EXTENDER DURING USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9260684 ↗MalfunctionOct 31, 2019Break
ONE OF THE TABS BROKE OFF THE SCREW EXTENDER DURING USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9260264 ↗MalfunctionOct 31, 2019Break
ONE TAB BROKE OFF BOTH SCREW EXTENDERS DURING USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9260126 ↗MalfunctionSep 24, 2019Break; Failure to Advance
BOTH TABS OF THE SCREW EXTENDER WERE BROKEN DURING THE SURGERY. THE SURGEON HEARD A CLICK WHEN INSERTING THE REDUCER BUT CONTINUED INSERTING THE SET SCREW. THEN DRIVER COULD NOT GO IN DEPTH AND THE SURGEON TRIED EXTENDING THE ITEM OUTWARD, BUT SOMETHING WAS INTERFERING. WHEN REMOVING THE SCREW EXTENDER AFTER FINAL TIGHTENING, THE TABS WERE FOUND BROKEN. ALL BROKEN FRAGMENTS WERE RETRIEVED AND NO RESIDUAL PARTS REMAIN IN THE PATIENT'S BODY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9109654 ↗MalfunctionAug 16, 2018Break
AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED A PART OF THE WING IS BROKEN.
Patient problems: No Information
MAUDE report 7789886 ↗MalfunctionJun 20, 2018Break
AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THE WING BROKE OFF.
Patient problems: No Information
MAUDE report 7620553 ↗MalfunctionJun 20, 2018Break
AN INTERNATIONAL CUSTOMER (GERMANY) REPORTED THE WING BROKE OFF.
Patient problems: No Information
MAUDE report 7620414 ↗MalfunctionJun 20, 2018Break
AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED A PART OF THE WING IS BROKEN.
Patient problems: No Information
MAUDE report 7620174 ↗InjuryJun 14, 2018Difficult to Remove
DURING AN MIS CASE, THE SURGEON ENCOUNTER DIFFICULTY REMOVING 3 OF 8 SCREW EXTENDERS FROM THE MATING POLYAXIAL SCREWS. HE WAS ABLE TO DETACH THEM BY REMOVING PART OF THE INSTRUMENT. THE EVENT CAUSED APPROXIMATELY A 40 MINUTE DELAY IN THE CASE.
Patient problems: Complaint, Ill-Defined
MAUDE report 7600742 ↗MalfunctionMay 18, 2018Break
AN INTERNATIONAL CUSTOMER (B)(6) REPORTED A PART OF THE WING IS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7526232 ↗MalfunctionApr 25, 2017Break
AN INTERNATIONAL CUSTOMER (B)(6) REPORTED THAT ONE OF THE WINGS IS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6519201 ↗MalfunctionApr 25, 2017Break; Entrapment of Device
WHEN TRYING TO REMOVE SLEEVE AFTER FINAL TIGHTENING ONE OF THE TABS BROKE OFF OF THE SLEEVE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6519122 ↗MalfunctionApr 17, 2017Break
AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT THE WING ON AN ILLICO SCREW EXTENDER IS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6498315 ↗MalfunctionMar 6, 2017Break
AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT THE WINGS ON AN ILLICO SCREW EXTENDERS ARE BROKEN.
Patient problems: No Information
MAUDE report 6380725 ↗MalfunctionFeb 22, 2017Break
AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT ONE OF THE WINGS ON AN ILLICO SCREW EXTENDERS IS BROKEN.
Patient problems: No Information
MAUDE report 6349326 ↗MalfunctionDec 13, 2016Break
AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT ONE OF THE WINGS ON AN ILLICO SCREW EXTENDERS IS BROKEN.
Patient problems: No Information
MAUDE report 6171626 ↗MalfunctionNov 30, 2016Break
AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT ONE OF THE WINGS ON AN ILLICO SCREW EXTENDERS IS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6136129 ↗MalfunctionNov 17, 2016Break
AN INTERNATIONAL CUSTOMER (B)(6) REPORTED THAT ONE OF THE WINGS ON AN ILLICO SCREW EXTENDERS BROKE DURING THE OPERATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6110455 ↗MalfunctionOct 24, 2016Break
AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT ONE OF THE WINGS ON AN ILLICO SCREW EXTENDERS IS BROKEN.
Patient problems: No Information
MAUDE report 6051756 ↗MalfunctionOct 11, 2016Break
AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT ONE OF THE WINGS ON AN ILLICO SCREW EXTENDERS IS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6018730 ↗MalfunctionSep 14, 2016Break
AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT ONE OF THE WINGS ON AN ILLICO SCREW EXTENDERS IS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5950284 ↗InjuryJul 26, 2016Break
WHILE REDUCING THE ROD, THE SLEEVE OF THE EXTENDER SNAPPED. THE SURGEON WANTED TO FINAL TIGHTEN THE OTHER SCREWS SO HE REMOVE THE EXTENDER SLEEVE GIVING HIM MORE ROOM TO REATTACH THE SLEEVE THAT BROKE LOOSE. THE EVENT CAUSED OVER A 30 MINUTE DELAY IN THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5822979 ↗MalfunctionJun 9, 2016Break
AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT ONE OF THE WINGS ON AN ILLICO SCREW EXTENDERS IS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5710000 ↗
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- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.