EXPEDIUM 179774555Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034078120), received between Oct 1, 2019 and Aug 28, 2024 — classified as 4 injuries, 5 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 (K092626, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2024Migration; Migration

  IT WAS REPORTED THROUGH LEGAL DOCUMENTATION, THE PATIENT SUSTAINED INJURIES DUE TO A CAR ACCIDENT ON FEBRUARY 2020. SUBSEQUENTLY, ON (B)(6) 2020, PLAINTIFF THE UNDERWENT AN OCCIPUT-C3 POSTERIOR SPINAL FUSION WHERE BONE SCREWS AND TITANIUM RODS WERE PLACED IN HER CERVICAL SPINE. PATIENT HAD GOOD RECOVERY. ON (B)(6) 2020, PATIENT WAS SEEN AND X-RAYS LEFT THE IMPRESSION OF AN ¿INSTRUMENTED POSTERIOR SPINAL FUSION AND POSTERIOR DECOMPRESSION FROM THE OCCIPUT THROUGH C3 FOR MANAGEMENT OF CERVICAL SPINE FRACTURES.¿ ALSO, X-RAYS OF HER RIGHT SHOULDER SHOWED A CLAVICULAR FRACTURE AND THORACIC COMPRESSION FRACTURES AT THE T5 AND T6 LEVELS. PLAINTIFF WAS DIAGNOSED WITH A ¿CLOSED STABLE BURST FRACTURE OF FIRST CERVICAL VERTEBRAE WITH ROUTINE HEALING.¿ ON (B)(6) 2020 PATIENT WAS SEEN AND WAS NOTED DOING PHYSICAL THERAPY AND WAS IMPROVING. ON (B)(6) 2020 CT SCANS OF THE CERVICAL AND THORACIC SPINE SHOWED: OCCIPUT-C3 POSTERIOR BONE FUSION WITHOUT EVIDENCE FOR HARDWARE FAILURE¿ AND FRACTURES AT THE T3-T6 LEVELS. ON (B)(6) 2020, PATIENT WAS TREATED FOR PAIN MANAGEMENT AND WAS DIAGNOSED WITH CERVICALGIA AND PAIN IN THE THORACIC SPINE. ON (B)(6) 2020 PATIENT WAS SEEN AND X-RAYS OF THE CERVICAL AND T

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Autoimmune Disorder; Distress; Dysphagia/ Odynophagia; Fall; Fatigue; Headache; Laceration(s); Loss of Range of Motion; Nausea; Necrosis; Nerve Damage; Numbness; Pain; Physical Asymmetry; Speech Disorder; Unspecified Nervous System Problem

  MAUDE report 20090906 ↗
• InjuryAug 28, 2024Migration; Migration

  IT WAS REPORTED THROUGH LEGAL DOCUMENTATION, THE PATIENT SUSTAINED INJURIES DUE TO A CAR ACCIDENT ON FEBRUARY 2020. SUBSEQUENTLY, ON (B)(6) 2020, PLAINTIFF THE UNDERWENT AN OCCIPUT-C3 POSTERIOR SPINAL FUSION WHERE BONE SCREWS AND TITANIUM RODS WERE PLACED IN HER CERVICAL SPINE. PATIENT HAD GOOD RECOVERY. ON (B)(6) 2020, PATIENT WAS SEEN AND X-RAYS LEFT THE IMPRESSION OF AN ¿INSTRUMENTED POSTERIOR SPINAL FUSION AND POSTERIOR DECOMPRESSION FROM THE OCCIPUT THROUGH C3 FOR MANAGEMENT OF CERVICAL SPINE FRACTURES.¿ ALSO, X-RAYS OF HER RIGHT SHOULDER SHOWED A CLAVICULAR FRACTURE AND THORACIC COMPRESSION FRACTURES AT THE T5 AND T6 LEVELS. PLAINTIFF WAS DIAGNOSED WITH A ¿CLOSED STABLE BURST FRACTURE OF FIRST CERVICAL VERTEBRAE WITH ROUTINE HEALING.¿ ON (B)(6) 2020 PATIENT WAS SEEN AND WAS NOTED DOING PHYSICAL THERAPY AND WAS IMPROVING. ON (B)(6) 2020 CT SCANS OF THE CERVICAL AND THORACIC SPINE SHOWED: OCCIPUT-C3 POSTERIOR BONE FUSION WITHOUT EVIDENCE FOR HARDWARE FAILURE¿ AND FRACTURES AT THE T3-T6 LEVELS. ON (B)(6) 2020, PATIENT WAS TREATED FOR PAIN MANAGEMENT AND WAS DIAGNOSED WITH CERVICALGIA AND PAIN IN THE THORACIC SPINE. ON (B)(6) 2020 PATIENT WAS SEEN AND X-RAYS OF THE CERVICAL AND T

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intervertebral Disc Compression or Protrusion

  MAUDE report 20088920 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: 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: ADJACENT SEGMENT PATHOLOGY. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND VIPER PRIME CFX FENESTRATED PRODUCTS. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18452868 ↗
• MalfunctionJul 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DENMARK REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, IT WAS FOUND THAT THE SMALL LOCKING SCREW IN THE EXPEDIUM CONNECTOR COULD NOT BE TIGHTENED. THE SMALL SCREW IS WRONGLY PLACED IN THE THREAD. OTHER CONNECTORS WERE USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT OUTCOME. THIS REPORT IS FOR A EXPEDIUM SPINE SYSTEM VARIABLE OPEN/CLOSED PIVOTING CONNECTOR 5.5 X 5.5-6.35MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15069156 ↗
• MalfunctionAug 25, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CONNECTOR WAS FOUND TO HAVE COME LOOSE. THE ISSUE WAS FOUND DURING STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CONN O/C ANGLD 5.5-6.35X5.5TI. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366512 ↗
• MalfunctionAug 11, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE SCREW COULD NOT BE COMPLETELY SCREWED IN; THE THREAD DID NOT RUN PROPERLY. THE SET CONTAINED MULTIPLE SCREWS, AND THOSE WERE USED INSTEAD. PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR A CONN O/C ANGLD 5.5-6.35X5.5TI. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307040 ↗
• MalfunctionApr 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE UNIVERSAL CONNECTOR CAP THREAD WAS OUT WHEN SURGEON CLOSED THE CAP AND THE CAP DRIVER SHAFT WAS WORN AWAY. THE ROD WAS BROKEN WHEN THE SURGEON USED THE IN-SITU BENDER. THERE WAS NO FRAGMENT GENERATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 20-MINUTES DELAY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) CONN O/C ANGLD 5.5-6.35X5.5TI. THIS REPORT IS 5 OF 6 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753779 ↗
• MalfunctionApr 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE UNIVERSAL CONNECTOR CAP THREAD WAS OUT WHEN SURGEON CLOSED THE CAP AND THE CAP DRIVER SHAFT WAS WORN AWAY. THE ROD WAS BROKEN WHEN THE SURGEON USED THE IN-SITU BENDER. THERE WAS NO FRAGMENT GENERATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 20-MINUTES DELAY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) CONN O/C ANGLD 5.5-6.35X5.5TI. THIS REPORT IS 2 OF 6 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753767 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DATE: (B)(6) 2019, 4 PM. EVENT DESCRIPTION: BROKEN RODS AND METALLOSIS. DATE J&J BECAME AWARE: (B)(6) 2019, 4 PM. NAME OF REPORTER: (B)(6). HOSPITAL NAME: (B)(6). HOSPITAL TOWN: (B)(6). PRODUCT: COCR 5.5 MM ROD, DI EXPEDIUM SCREWS, UNITISED SET SCREWS, CONNECTOR. LOT/BATCH/EXP: UNKNOWN. PRODUCT NUMBER: 179774555, 179722050, 179722644, 198769480. DID THE EVENT HAPPEN DURING A PROCEDURE? NO. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. EVENT OUTCOME/HOW WAS IT MANAGED? RODS REPLACED, BLOOD WAS NOT USED WHEN SEDIMENT DISCOVERED. WAS THERE A PATIENT IMPACT OR WAS THE PROCEDURE DUE TO THE FAILURE? PATIENT HAS METALLOSIS. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? HOPEFULLY IF RETURNED FROM STERILISATION SUCCESSFULLY. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: THE PATIENT WAS UNDERGOING REVISION SURGERY IN WHICH THE COCR RODS HAD SNAPPED ON BOTH THE LEFT AND THE RIGHT SIDE. THE SURGEON REMOVED SET SCREWS, RODS CONNECTORS AND SCREWS. UPON REMOVAL OF THE METAL WORK, THERE WAS CONSIDERABLE METALLOSIS ON THE PATIENT¿S TISSUE. THE ANESTHETIST WAS USING CELL

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9139944 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092626, 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