Synex 04.807.233Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034753089), received between Jun 18, 2018 and Jun 18, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

11 other recalls cover devices cleared under the same FDA submission (K003836); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryJun 18, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L3 CORPECTOMY/ANTERIOR SPINAL FUSION ON (B)(6) 2018. DURING THE PROCEDURE, THE SURGEON OVER-DISTRACTED THE EXPANDABLE SYNEX CAGE BEYOND ITS STOPPING MECHANISM AND IT CAME APART WHILE IMPLANTING IT. THE SURGEON WAS ABLE TO COLLAPSE THE CAGE BACK DOWN AND MANIPULATION WAS REQUIRED TO REMOVE THE IMPLANT. THE SURGEON WENT ON TO IMPLANT A DEPUY SPINE DEVICE (X-MESH POSTERIOR CAGE - MEDIUM 0 DEGREE 40-56MM). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN APPROXIMATE TEN (10) MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR A SYNEX(TM) W/LRG ENDPLATE/OPEN 10 DEG/33MM-48MM HEIGHT (TI). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7610533 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K003836. One submission often covers many models, so check the product and lot details in each record.

• Z-0114-2010 · Sep 14, 2009 · Terminated
  Synthes USA, TI Synex (TM) II Central Body 45mm - 71mm, Catalog number 04.808.007. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable
• Z-0109-2010 · Sep 14, 2009 · Terminated
  Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm, Catalog number 04.808.002. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable
• Z-0113-2010 · Sep 14, 2009 · Terminated
  Synthes USA, TI Synex (TM) II Central Body 37mm - 52mm, Catalog number 04.808.006. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable
• Z-0116-2010 · Sep 14, 2009 · Terminated
  Synthes USA, TI Synex (TM) II Central Body 71mm - 97mm, Catalog number 04.808.009. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable
• Z-0112-2010 · Sep 14, 2009 · Terminated
  Synthes USA, TI Synex (TM) II Central Body 29mm - 44mm, Catalog number 04.808.005. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable
• Z-0118-2010 · Sep 14, 2009 · Terminated
  Synthes USA, TI Synex (TM) II Central Body 97mm - 123mm, Catalog number 04.808.011. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstabl
• Z-0111-2010 · Sep 14, 2009 · Terminated
  Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number 04.808.004. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable
• Z-0117-2010 · Sep 14, 2009 · Terminated
  Synthes USA, TI Synex (TM) II Central Body 84mm - 110mm, Catalog number 04.808.010. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstabl
• Z-0115-2010 · Sep 14, 2009 · Terminated
  Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog number 04.808.008. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable
• Z-0110-2010 · Sep 14, 2009 · Terminated
  Synthes USA, TI Synex (TM) II Central Body 21mm - 29mm, Catalog number 04.808.003. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable
• Z-0108-2010 · Sep 14, 2009 · Terminated
  Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog number 04.808.001. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable