EXPEDIUM SFX 189401405Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034168128), received between Jun 25, 2019 and Nov 13, 2024 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K062196, K111136, K142460); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THIS WAS A PSF FOR A TRAUMA TO THE LUMBAR VERTEBRAE ON NOVEMBER 3, 2024. DURING THE SURGERY, THE TIP OF THE SFX X20 TORQUE DRIVER SHAFT GETS STRIPPED WHEN IT IS USED FOR TIGHTENING THE CROSS CONNECTOR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675724 ↗
• InjuryJun 12, 2024Break; Migration; Break; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2024, DUE TO SCREW DISPLACEMENT AND MIGRATION. IN THE SURGERY, IT WAS CONFIRMED THAT SFX BROKE OFF AS WELL AS THE REPORTED SCREWS. THE DEVIATED SCREW WAS REPLACED. THE FENESTRATED SCREWS WERE ADDED FOR THE EXTENSION ON UPPER VERTEBRAE. ALL OF THE SET SCREW WERE REPLACED. SFX WAS PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS STABLE THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2024 AND WAS FOR A SPINAL FUSION (L5/S) (L4-SAI FUSION USING VERSE), FOR PSEUDARTHROSIS ON MARCH 29, 2024. PATIENT WAS STABLE. ORIGINAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IT WAS NOTED POST-OPERATIVELY ON AN UNKNOWN DATE THAT THE SCREWS HAD MIGRATED. THIS REPORT INVOLVES ONE (1) SFX,5.5,TI, MED, SIZE A5 THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19519019 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED AN UNKNOWN SPINE SURGERY OCCURRED ON (B)(6) 2018. POST OPERATIVELY, THE EXTENDED RE-FUSION SURGERY WILL BE PERFORMED DUE TO THE ADJACENT INTERVERTEBRAL DISORDERS. IT IS CONFIRMED L4/5 ACHIEVED OSTEOSYNTHESIS. THE PLAN IS TLIF FOR L2/3, AND L5 MIGHT BE REMOVED DEPENDING ON INTRAOPERATIVE DECISION. NO FURTHER INFORMATION IS AVAILABLE. (B)(4) AND PC-001504502 ARE LINKED TO (B)(4). (B)(4) (DEPUY SPINE): SCREWS. (B)(4) (SYNTHES SPINE): CAGES. THIS REPORT IS FOR ONE EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A5 5.5 X 41-49MM FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18476316 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION (L3/4) ON (B)(6) 2014 AFTER SURGERY, ADJACENT INTERVERTEBRAL DISORDER OCCURRED AT L2/3 AND L4/5. ON (B)(6) 2023, A REOPERATION WAS PERFORMED. IN THE REOPERATION, SET SCREWS AND RODS OF L3/4 WERE REMOVED, AND SCREWS WERE ADDED TO L2 AND L5. TLIF TREATING L2/3 AND TLIF TREATING L4/5 WERE DONE. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THERE IS NO PROBLEM IN THE FUSION SITE TREATED IN THE INITIAL SURGERY IN 2024. THIS REPORT INVOLVES ONE EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A5 5.5 X 41-49MM. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 16644048 ↗
• MalfunctionOct 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A REMOVAL PROCEDURE (L4, L5) ON (B)(6) 2022, THE TIP OF THE DRIVER SHAFT BROKE OFF AND GOT STUCK TO A SETSCREW OF THE CROSS LINK. THE SURGEON MANAGED TO REMOVE THE CROSS LINK. THE SURGEON COMMENTED THAT THE SETSCREW ON THE CROSS LINK HAD BEEN QUITE TIGHT WHEN THEY TRIED TO LOOSEN IT WITH THE DRIVER SHAFT. PROCEDURE WAS COMPLETED WITH LESS THAN THIRTY MINUTES DELAY. THIS REPORT IS FOR A EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A5 5.5 X 41-49MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692518 ↗
• MalfunctionMar 14, 2022Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A REVISION PROCEDURE (POSTERIOR THORACOLUMBAR FUSION) IN THE THORACIC VERTEBRA, THE SURGEON DEPLOYED THE CROSS LINK AND TRIED TO TIGHTEN THE SIDE SCREW. HOWEVER, THE SURGEON WAS NOT ABLE TO TIGHTEN THE SCREW BECAUSE THE SCREWHEAD STRIPPED. THIS REPORT INVOLVES ONE (1) SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13760681 ↗
• MalfunctionMar 10, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, THE TRANSVERSE SYSTEM LOCKING NUT WAS DAMAGED WHILE TIGHTENING AND IT WAS IMPOSSIBLE TO UNSCREW IT. THE SURGEON HAD TO USE ANOTHER TRANSVERSAL LIAISON AND CHANGE THE SCREWS. THERE WAS A THIRTY (30) MINUTES SURGICAL DELAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) SFX,5.5,TI, MED, SIZE A5 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13726265 ↗
• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT THE PRIMARY TLIF (L5/6) PROCEDURE FOR TREATING BOTH LUMBAR INTERVERTEBRAL FORAMEN STENOSIS AND LUMBAR DISC HERNIA ON (B)(6) 2021. ON (B)(6), THE PATIENT UNDERWENT A HEMATOMA REMOVAL PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) SFX,5.5,TI, MED, SIZE A5. THIS REPORT IS 7 OF 9 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: Hematoma

  MAUDE report 13090703 ↗
• InjuryDec 11, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RODS FRACTURED AT T12 LEVEL AND SCREWS BROKEN AT L5 LEVEL. REVISION SURGERY TO REPLACE RODS AND EXTEND CONSTRUCT TO S1 AND PELVIS WAS PERFORMED. NO PROBLEMS DURING PROCEDURE. THIS REPORT IS FOR ONE (1) SFX, 5.5, TI, MED, SIZE A5. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9452905 ↗
• InjuryJun 25, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED ON (B)(6) 2019, AFTER A REVISION SURGERY LAST (B)(6) 2019, THE SURGEON RECOGNIZED THAT THE BOTH SET SCREW AND ROD WERE CAME OFF DISSOCIATED UNDER X-RAY. SURGEON SUSPECTED THAT THE DAMAGE OF THE SCREW THREAD WAS BECAUSE THE SURGEON DID NOT TIGHTEN THE SET SCREW FORCIBLY. THE REVISION SURGERY PERFORMED ON (B)(6) 2019. PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE PATIENT¿S CONDITION IS NOW STABLE AND UNDER MONITORING. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8732293 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062196, K111136, K142460. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2015 · Apr 21, 2015 · Terminated
  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467