Illico 73600-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844856043497), received between May 10, 2017 and May 10, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K123623); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2017Break

  PATIENT ORIGINALLY HAD L5/S1 SYNOVIAL CYSTECTOMY IN (B)(6) 2013. HE WENT INTO THE HOSPITAL WITH A COMPLAINT OF SEVERE BACK PAIN RADIATING TO THE LEFT THIGH AND LOWER EXTREMITIES. ON (B)(6) 2015 AN L5/S1 TLIF WAS THEN PERFORMED IN WHICH ALPHATEC INSTRUMENTATION WAS UTILIZED. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2016 TO PERFORM A L3-L5 DECOMPRESSION AND S1 BILATERAL SCREW REVISION. THE PATIENT HAD DEVELOPED LEFT-SIDE LOW BACK PAIN WITH SOME CLAUDICATION COMPONENT. CT MYELOGRAPHY SHOWED CANAL STENOSIS AT THE L3-L4 AND L4-L5 IN THE SETTING OF EPIDURAL LIPOMATOSIS. THE PATIENT ALSO HAD OSTEOLYSIS AROUND THE BILATERAL S1 SCREW. DURING THE CASE, THE INTERVENING ROD (L5/S1) WAS REMOVED AND FOUND TO BE BROKEN IN TWO (2) DISCRETE PIECES. THIS HAD NOT BEEN APPRECIATED ON THE CT MYELOGRAPHY IMAGES. ADDITIONALLY, THE EPIDURAL SPACE WAS ENCOUNTERED AND EXPLORED. THE DORSAL ASPECT OF THE PEEK INTERBODY CAGE ON THE LEFT SIDE WAS IDENTIFIED. IT APPEARS TO BE SOLIDLY LODGED INTO PLACE AND, THUS, NO ADDITIONAL MANIPULATION OR AUGMENTATION OF THE INTERBODY FUSION WAS FELT TO BE INDICATED.

  Patient problems: Failure of Implant; Osteolysis; Pain; Stenosis

  MAUDE report 6558744 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123623. One submission often covers many models, so check the product and lot details in each record.

• Z-2086-2013 · Jun 28, 2013 · Terminated
  Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by p