Synex 495.316Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034785059), received between May 20, 2020 and May 20, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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.

• InjuryMay 20, 2020Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THAT A SYNEX WITH LARGE ENDPLATE WAS IMPLANTED INTO A PATIENT. THE PATIENT HAD A MEDULLARY SECTION DONE APPROXIMATELY EIGHT (8) YEARS AGO. THE PROCEDURE WAS PERFORMED TO PROVIDE ADDITIONAL STABILITY, TO THE COLUMN AS PREVENTION OF DAMAGE IN LARGE VESSELS OF THE ABDOMEN, GIVEN THE DISPOSAL OF ANTERIOR VERTEBRAL FRAGMENTS THAN TO PRESERVE NERVOUS STRUCTURES. THE SPECIALIST DECIDED TO PERFORM AN APPROACH VIA POSTERIOR WAY TO REMOVE ALL BONE AND VERTEBRAL FRAGMENTS AND IMPLANT THE EXPANDABLE CYLINDER. GIVEN THE ANATOMICAL ALTERATIONS OF THE PATIENT, DUE TO THE UNSOLVED TRAUMA YEARS AGO, THE CYLINDER WAS LOCATED BETWEEN THE POSTERIOR AND ANTERIOR ARCH, AS A BETTER ALIGNMENT OF THE SPINE WAS NOT POSSIBLE. THERE WAS NO REPORTED CONSEQUENCE TO THE PATIENT, AND THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. THIS REPORT INVOLVES ONE (1) SYNEX(TM) WITH LARGE ENDPLATE 0 DEG/23MM-31MM HEIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10074417 ↗

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-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-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-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-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-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-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-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
• 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-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