EXPEDIUM SFX 189401406Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705034168135), received between Jul 24, 2019 and Sep 16, 2025 — classified as 8 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING THE SURGERY, THE CONNECTOR COULDN'T BE INSTALLED AS IT WAS, SO AFTER BENDING IT AND INSTALLING IT AGAIN SEVERAL TIMES, THE THREADS ON THE SET SCREW BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINS OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062806 ↗
• InjuryJan 29, 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 THAT THIS WAS AN ORIGINAL UNKNOWN SURGERY OCCURRED ON (B)(6), 2020. POST-OPERATIVELY ON AN UNKNOWN DATE, ADJACENT SEGMENT DISEASE (ASD) OCCURRED. A REVISION SURGERY OCCURRED TO EXTEND FIXATION AND REMOVE HARDWARE ON (B)(6), 2023. THE SFX CROSS-LINK WAS REMOVED. SET SCREW AND ROD WERE REMOVED. OF THE SCREWS IN L3-5, ONLY L3 AND L4 SCREWS WERE REMOVED. (BONE FUSION WAS COMPLETED) L5 SCREW WERE PRESERVED. S ADDITIONAL SCREW OF 7.0-45MM DIAMETER WAS INSERTED. L5-S TLIF WAS PERFORMED.(CAGE WAS OTHER COMPANY¿S PRODUCT.) SFX CROSS-LINK WAS PLACED, AND THE FINAL TIGHTENING WAS DONE. THIS REPORT IS FOR ONE EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A6 5.5 X 49-66MM FOR (B)(6). (B)(6) ARE LINKED. ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED FOR THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 18597905 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: CEREBRAL, WOUND INFECTION SUPERFICIAL, POSTOPERATIVE INFECTION DEEP, WOUND HEALING PROBLEM. COMPLICATION TIME/INTERVENTION. POSTOPERATIVE (BEFORE DISCHARGE). THIS REPORT IS FOR ONE (1) SFX,5.5,TI, MED, SIZE A6. THIS IS REPORT 1 OF 4 FOR COMPLAINT: (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: Impaired Healing; Insufficient Information; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 18458737 ↗
• InjuryNov 2, 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 THERE WAS POSTERIOR LUMBAR INTERBODY FUSION (L4/5) PERFORMED ON (B)(6) 2014. AFTER THE SURGERY, ASD OCCURRED. THE REOPERATION TO EXTEND FIXATION WILL BE PERFORMED ON (B)(6) 2023. THE EXP SINGLE INNER SETSCREW, MMSI ROD AND SFX 5.5 TRANSV CONN 49-66 MM IN QUESTION WILL BE REPLACED. 5.5 CANNULATED CORTICAL FIX SCREW 6X40MM AND CONC BULLET PARALLEL IN QUESTION WILL BE PRESERVED. THE EXTENSION SURGERY (L/S2) WILL BE PERFORMED WITH ALAR ILIAC, OLIF WILL BE PERFORMED FOR L2/3 AND L3/. THIS REPORT INVOLVES ONE (1) EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A6 5.5 X 49-66MM. THIS IS REPORT 8 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18055377 ↗
• InjurySep 27, 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: THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE EVENT OCCURRED IN THE REOPERATION. THIS PC REPORTS ABOUT THE INITIAL SURGERY AND THE SUBSEQUENT NEED FOR AN EXTENDED FIXATION. IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2023. AFTER THE INITIAL SURGERY, AN EXTENDED FIXATION WAS NEEDED, AND A REOPERATION WAS SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE. REMARKS: (B)(4) AND (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (SYNTHES SPINE): RODS, (B)(4) (DEPUY SPINE): SCREWS, SET SCREWS, (B)(4) (DEPUY SPINE): SCREWS, SET SCREWS, SFX CROSS CONNECTOR. THIS REPORT IS FOR ONE (1) SFX,5.5,TI, MED, SIZE A6. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17824195 ↗
• InjurySep 26, 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 AN UNKNOWN SURGERY WAS PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, A REOPERATION VIA POSTERIOR FUSION (L3 ¿ S2) WAS PERFORMED TO EXTEND FIXATION. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A6 5.5 X 49-66MM. THIS REPORT IS RELATED TO PC-(B)(4), WHICH CAPTURES THE RODS INVOLVED IN THIS EVENT. THIS REPORT IS RELATED TO PC-(B)(4), WHICH REPORTS A DEVICE MALFUNCTION THAT OCCURRED DURING THE REVISION SURGERY. THIS IS REPORT 6 OF 13 FOR PC-(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17818348 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED TO CAPTURE THE ADDITIONAL IPS.

  Patient problems: Osteolysis

  MAUDE report 17790138 ↗
• MalfunctionMay 4, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING A PLIF WHILE THE FINAL TIGHTENING, TORQUE WAS NOT APPLIED TO THE SFX CROSS CONNECTOR EVEN THOUGH THE SURGEON TIGHTENED WITH CONSIDERABLE FORCE. AFTER MANY ATTEMPTS TO TIGHTEN, THE SET SCREW OF THE SFX CROSS CONNECTOR GOT STRIPPED AND THE SFX CROSS CONNECTOR COULD NOT BE REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY(30) MINUTES OF SURGICAL DELAY. THE SFX CROSS CONNECTOR IN QUESTION IS A CONSIGNMENT AND THUS NO MAINTENANCE/CHECK IS PERFORMED ON THE VALUES OF TORQUE. THE TIP OF THE SFX TORQUE DRIVER SHAFT MAY HAVE BEEN STRIPPED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A6 5.5 X 49-66MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872956 ↗
• MalfunctionOct 19, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON PERFORMED AN INTERBODY FUSION (L3 TO L5) FOR SPONDYLOLISTHESIS. THE LEFTMOST OF THE THREE SET SCREWS WAS PROPERLY TORQUED BY THE TORQUE DRIVER SHAFT IN QUESTION. THE RIGHTMOST SET SCREW DID NOT TORQUE OUT, AND THE TIP OF THE TORQUE DRIVER SHAFT GOT STRIPPED. ALTHOUGH THE SURGEON TRIED TO TORQUE THE SET SCREW SEVERAL TIMES, THE DRIVER SHAFT WAS IDLED. THE CENTER SET SCREW ALSO DID NOT TORQUE OUT DUE TO IDLING OF THE TORQUE DRIVER SHAFT. THE SURGEON TIGHTENED THE SET SCREWS WITH A QC POLYAXIAL SCREWDRIVER. THE RIGHTMOST SET SCREW ITSELF GOT STRIPPED, AND THE CENTER SET SCREW WAS TIGHTENED TO SOME EXTENT. NONETHELESS THE SET SCREWS GOT STRIPPED, THE TRANSVERSE WAS TIGHTENED TO SOME EXTENT. THE SURGEON DETERMINED THAT IT WAS DIFFICULT TO REPLACE THE TRANSVERSE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. IT WAS CONFIRMED BY X RAYS THAT THERE WERE NO BROKEN PIECES IN THE PATIENT¿S BODY. THIS REPORT INVOLVES ONE EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A6 5.5 X 49-66MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15630862 ↗
• MalfunctionJun 16, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON 18-MAY-2022, THE OUTER SCREW OF THE CONNECTOR GOT STRIPPED DURING FINAL TIGHTENING. THE FINAL SCREW TIGHTENING WAS NOT ATTAINED, BUT THE SCREW HAD BEEN TIGHTENED TO A CERTAIN EXTENT. THE PROCEDURE WAS COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES. THIS REPORT IS FOR A EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A6 5.5 X 49-66MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14711446 ↗
• InjuryMar 3, 2022Adverse 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 THAT, ON MAY 22 2018 THE PATIENT UNDERWENT THE PRIMARY POSTERIOR LUMBAR INTERBODY FUSION (PLIF) (L4-5). ON (B)(6) 2022 IT WAS FOUND THAT THE PATIENT HAD SUFFERED FROM ASD AND ON (B)(6) 2022 THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE (PLIF EXTENSION BETWEEN L3-4). THE UPCOMING REVISION PROCEDURE WAS PLANNED TO REMOVE DEVICES IN QUESTION FROM THE LESION AND RECONNECTED FROM L3 AND TO DEPLOY SCREWS IN L4-5 WILL BE LEFT IN PLACE BECAUSE THEY HAVE BEEN TIGHT ENOUGH IN THE LESION. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) SINGLE-INNER SETSCREW. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13660534 ↗
• MalfunctionOct 4, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THIS WAS A PLIF (L4-S) FOR TREATING SPONDYLOLISTHESIS. THE CROSS CONNECTOR BROKE OFF DURING BENDING. PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THIS REPORT IS FOR ONE (1) EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A6 5.5 X 49-66MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572665 ↗
• MalfunctionMar 24, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A SPINAL FUSION AT L5-S PROCEDURE TREATING SACRAL BONE FRACTURE, THE CONNECTOR WAS BENT TO MAKE THE CONTOUR FIT IN THE LESION. THE SFX ON THE SLIDING COMPONENT BROKE DURING BENDING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT. THERE WAS NO SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN BENDER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS REPORT IS FOR ONE (1) SFX,5.5,TI, MED, SIZE A6. THIS IS REPORT 1 OF 1 FOR PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11565971 ↗
• MalfunctionNov 17, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT L3-L4 PROCEDURE, THE SURGEON USED THE DRIVER SHAFT FOR TIGHTENING THE SFX CONNECTOR. THEN, THE TIP OF THE DRIVER SHAFT STRIPPED. THE SURGEON KEPT USING THE DEVICE AND COMPLETED THE REST OF THE PROCEDURE WITHOUT SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SFX,5.5,TI, MED, SIZE A6. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10853595 ↗
• InjuryJul 24, 2019Break; Break

  EVENT: THE EXPEDIUM TITANIUM BARS AND THE SFX BROKE INSIDE THE PATIENT AFTER A FALL, WHICH LED TO THE SURGICAL NECESSITY OF THE SAME. MEDICAL REPORT: MATERIAL TAKEN FROM THE ATN PATIENT, ON (B)(6) 2019, IN THIS HOSPITAL BY DR. (B)(6). MATERIAL WAS BROKEN, ACCORDING TO X-RAY ATTACHED, AFTER THE PATIENT SUFFERED A FALL. I LEAVE THE MATERIAL IN THE POSSESSION OF THE NURSES (B)(6) FOR LATER WITHDRAWAL FROM THE HOSPITAL FOR OUR LOGISTICS. SALES REP COMMUNICATED VIA (B)(6) THAT THE OPERATING COMPANY OF THE MATERIALS IS DEPUY SPINE, OF REFERENCES: TITANIUM ROD: 1797-62-300; SFX: 1894-014-06. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8822060 ↗

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