Synex 04.807.123Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034753027), received between Jan 30, 2017 and Jan 30, 2017 — 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.

• InjuryJan 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON THE MORNING OF (B)(6) 2017, A PATIENT UNDERWENT A T7 CORPECTOMY WITH T5-T9 POSTERIOR SPINAL FUSION AND FIXATION. EXPEDIUM TITANIUM (TI) PEDICLE SCREWS WERE PLACED BILATERALLY AT T5, T6, T8 & T9. TWO (2) 5.5MM TI RODS WERE PLACED USING TI EXPEDIUM SET SCREWS AND SFX CONNECTOR WAS PLACED OVER THE T7 CORPECTOMY SPACE (OVER THE CAGE). WHILE THE PATIENT WAS RECOVERING POST-OPERATIVELY, IT WAS REPORTED THAT SHE COULD NOT MOVE HER LOWER EXTREMITIES AND THAT A COMPUTERIZED TOMOGRAPHY (CT) SCAN SHOWED THAT A T5 PEDICLE SCREW WAS ON THE MEDIAL BORDER OF THE PEDICLE AND POSSIBLY TOUCHING THE SPINAL CORD. SHE WAS RETURNED TO SURGERY THAT SAME DAY. THE SURGEON REPOSITIONED THE SCREW IN THE PEDICLE UNDER ROUTINE FLUOROSCOPY. HE FOUND THE SYNEX CAGE (04.807.123) WAS NOT EXPANDED CORRECTLY. HE TRIED TO REPOSITION IT. THE ORIGINAL VOID IN THE FIRST SURGERY, EARLIER THAT DAY WAS 28MM. THIS CAGE WAS CHOSEN BECAUSE IT WAS LESS THAN THE VOID AND EXPANDED BEYOND THE NON-DISTRACTED VOID HEIGHT. HOWEVER, ALTHOUGH THE CAGE WOULD EXPAND IT WOULD NOT LOCK INTO PLACE. THE ROD WAS REMOVED ON THE PATIENT¿S RIGHT SIDE AND THE SET SCREWS WERE LOOSENED ON THE PATIENTS LEFT SIDE. HE REMOVED

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6287934 ↗

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-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-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-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-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-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-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-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-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-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-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-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