Illico 73965-50Recalls & reported problems
Alphatec Spine, Inc. · SACRAL CANNULATED POLYAXIAL SCREW 6.5MM X 50MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844856043299), received between Jun 13, 2016 and Jun 13, 2016 — 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
Device problems
- Break1
- Fracture1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2016Break; Fracture
A PATIENT RETURNED IN (B)(6) 2016 FOR A POST-OP VISIT AND REPORTED HAVING PAIN. X-RAYS TAKEN AT THE TIME CONFIRMED THE ILLICO SCREW LOCATED AT THE S1 HAD FRACTURED AND BROKE. REVISION SURGERY WAS CONDUCTED ON (B)(6) 2016 TO REMOVE THE FRACTURED 6.5MM SCREW AND REPLACE IT WITH A 7.5MM. THE ILLICO POSTERIOR FIXATION SYSTEM WAS ORIGINALLY IMPLANTED AT THE L5-S1 IN (B)(6) 2015.
Patient problems: Pain
MAUDE report 5721338 ↗
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 · TerminatedIllico 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
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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