EXPEDIUM TOP NOTCHRecalls & reported problems across all models

We found 2 models of EXPEDIUM TOP NOTCH by Depuy Spine, LLC in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2018 and Jan 27, 2026 — classified as 20 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EXPEDIUM TOP NOTCH problems

EXPEDIUM TOP NOTCH models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EXPEDIUM TOP NOTCH 179771555

  Orthosis, spondylolisthesis spinal fixation
  41 reports
• EXPEDIUM TOP NOTCH 179771655

  Orthosis, spondylolisthesis spinal fixation
  1 report

Recent EXPEDIUM TOP NOTCH adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191084 ↗
• MalfunctionApr 9, 2024Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT THE BRUCH DES EXPEDIUM SEITENKONNEKTOR. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) CONN O/O SD TOP NTCH 5.5X5.5 . THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074238 ↗
• MalfunctionFeb 15, 2024Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 THE INITIAL SURGERY WAS PERFORMED VIA POSTERIOR FUSION. IN THE SURGERY, THE SCREWS WERE INSERTED T10-L5, AND FUSION WAS PERFORMED WITH THE HOOKS. AFTER THE INITIAL SURGERY, THE SCREWS AND HOOKS ON L4 AND L5 WERE LOOSENED VIA POSTERIOR FUSION ON (B)(6) 2024. IN THE SURGERY, THE SURGEON CUT THE ROD BETWEEN L3 AND L4 INTERNALLY AND DID NOT DEPLOY CEPHALAD OF L3. THE SCREWS IN L4 AND L5 WERE REPLACED, AND AFTER INSERTION OF S1 AND S2AI SCREWS, THE RODS WERE CONNECTED AT L4-S2AI. HE ATTACHED THE UNIVERSAL CONNECTOR IN QUESTION TO THE ROD OF THE CUT L3 SECTION AND ANOTHER UNIVERSAL CONNECTOR IN QUESTION BETWEEN THE L5 AND S SCREWS, CONNECTING THE UPPER AND LOWER SECTIONS WITH THE ROD. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE SALES REP WAS INFORMED THAT THE UNIVERSAL CONNECTORS WERE DISCONNECTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM. THIS IS REPORT 2 OF 2 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711153 ↗
• MalfunctionFeb 15, 2024Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 THE INITIAL SURGERY WAS PERFORMED VIA POSTERIOR FUSION. IN THE SURGERY, THE SCREWS WERE INSERTED T10-L5, AND FUSION WAS PERFORMED WITH THE HOOKS. AFTER THE INITIAL SURGERY, THE SCREWS AND HOOKS ON L4 AND L5 WERE LOOSENED VIA POSTERIOR FUSION ON (B)(6) 2024. IN THE SURGERY, THE SURGEON CUT THE ROD BETWEEN L3 AND L4 INTERNALLY AND DID NOT DEPLOY CEPHALAD OF L3. THE SCREWS IN L4 AND L5 WERE REPLACED, AND AFTER INSERTION OF S1 AND S2AI SCREWS, THE RODS WERE CONNECTED AT L4-S2AI. HE ATTACHED THE UNIVERSAL CONNECTOR IN QUESTION TO THE ROD OF THE CUT L3 SECTION AND ANOTHER UNIVERSAL CONNECTOR IN QUESTION BETWEEN THE L5 AND S SCREWS, CONNECTING THE UPPER AND LOWER SECTIONS WITH THE ROD. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE SALES REP WAS INFORMED THAT THE UNIVERSAL CONNECTORS WERE DISCONNECTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711149 ↗
• MalfunctionFeb 8, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A THORACOLUMBAR POSTERIOR FUSION (LEFT S1-2) FOR SPINAL DEFORMITY ON (B)(6) 2024. IN THE SURGERY, THE THREADED PART WHERE THE SET SCREW OF THE IMPLANT IN QUESTION ENGAGES WAS DAMAGED, AND THE SET SCREW COULD NOT BE INSERTED PROPERLY. IT IS POSSIBLE THAT THE IMPLANT WAS SLIGHTLY DEFORMED BECAUSE IT WAS HAMMERED WHEN IT WAS PLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669915 ↗
• MalfunctionJan 9, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE REVISION SURGERY PERFORMED DUE TO THE BREAKAGE OF THE RODS. THIS PC REPORTS THE BREAKAGE OF SET SCREW AND CONNECTOR DURING THE REVISION SURGERY. IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION ON (B)(6) 2023 WITH THE SET SCREW AND CONNECTOR IN QUESTION. AFTER THE PRIMARY SURGERY, THE RODS IN RIGHT AND LEFT BROKE, AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. IN THE REVISION SURGERY, THE SURGEON PLACED A NEW COBACHROME ROD AT THE ROD BREAKAGE SITE USING THE UNIVERSAL CONNECTOR. AFTER TEMPORARY FIXATION OF THE SET SCREW, FINAL FASTENING WAS PERFORMED AND NO TORQUE WAS APPLIED. IT WAS DISCOVERED THAT THE SET SCREW BROKE. ON THE LEFT SIDE, THE SET SCREW AND CONNECTOR WERE REPLACED DUE TO POSSIBLE DAMAGE TO THE CONNECTOR AS WELL AS THE SET SCREW. FINAL FASTENING IS COMPLETED WITH NO PROBLEMS. WHEN THE COBACHROME ROD WAS INSTALLED ON THE RIGHT SIDE AS WELL, THE SAME EVENT OCCURRED AS ON THE LEFT SIDE. ON THE RIGHT SIDE, THE SET SCREW WAS REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 SURGICAL DELAY. PATIENT STATUS/ OUTCOME: STABLE THE SURGEON COMMENTED THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477248 ↗
• MalfunctionDec 12, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, AFTER FUSION TO T3-S2, THE TOP NOTCHES IN QUESTION WERE USED FOR KYPHOSIS CORRECTION. THE IMPLANTS COULD NOT WITHSTAND THE ORTHODONTIC FORCES AND MOVED ON THE RODS AFTER THE SET SCREWS WERE FASTENED. THE SURGEON REPLACED ALL THE PRODUCTS IN QUESTION WITH ONES FROM ANOTHER COMPANY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18311990 ↗
• MalfunctionDec 12, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON 20-NOVEMBER-2023, AFTER FUSION TO T3-S2, THE TOP NOTCHES IN QUESTION WERE USED FOR KYPHOSIS CORRECTION. THE IMPLANTS COULD NOT WITHSTAND THE ORTHODONTIC FORCES AND MOVED ON THE RODS AFTER THE SET SCREWS WERE FASTENED. THE SURGEON REPLACED ALL THE PRODUCTS IN QUESTION WITH ONES FROM ANOTHER COMPANY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18311989 ↗
• MalfunctionDec 12, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON 20-NOVEMBER-2023, AFTER FUSION TO T3-S2, THE TOP NOTCHES IN QUESTION WERE USED FOR KYPHOSIS CORRECTION. THE IMPLANTS COULD NOT WITHSTAND THE ORTHODONTIC FORCES AND MOVED ON THE RODS AFTER THE SET SCREWS WERE FASTENED. THE SURGEON REPLACED ALL THE PRODUCTS IN QUESTION WITH ONES FROM ANOTHER COMPANY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18311984 ↗
• MalfunctionDec 12, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, AFTER FUSION TO T3-S2, THE TOP NOTCHES IN QUESTION WERE USED FOR KYPHOSIS CORRECTION. THE IMPLANTS COULD NOT WITHSTAND THE ORTHODONTIC FORCES AND MOVED ON THE RODS AFTER THE SET SCREWS WERE FASTENED. THE SURGEON REPLACED ALL THE PRODUCTS IN QUESTION WITH ONES FROM ANOTHER COMPANY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18311982 ↗
• MalfunctionDec 12, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON 20-NOVEMBER-2023, AFTER FUSION TO T3-S2, THE TOP NOTCHES IN QUESTION WERE USED FOR KYPHOSIS CORRECTION. THE IMPLANTS COULD NOT WITHSTAND THE ORTHODONTIC FORCES AND MOVED ON THE RODS AFTER THE SET SCREWS WERE FASTENED. THE SURGEON REPLACED ALL THE PRODUCTS IN QUESTION WITH ONES FROM ANOTHER COMPANY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18311981 ↗
• MalfunctionDec 12, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, AFTER FUSION TO T3-S2, THE TOP NOTCHES IN QUESTION WERE USED FOR KYPHOSIS CORRECTION. THE IMPLANTS COULD NOT WITHSTAND THE ORTHODONTIC FORCES AND MOVED ON THE RODS AFTER THE SET SCREWS WERE FASTENED. THE SURGEON REPLACED ALL THE PRODUCTS IN QUESTION WITH ONES FROM ANOTHER COMPANY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18311980 ↗
• MalfunctionDec 12, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, AFTER FUSION TO T3-S2, THE TOP NOTCHES IN QUESTION WERE USED FOR KYPHOSIS CORRECTION. THE IMPLANTS COULD NOT WITHSTAND THE ORTHODONTIC FORCES AND MOVED ON THE RODS AFTER THE SET SCREWS WERE FASTENED. THE SURGEON REPLACED ALL THE PRODUCTS IN QUESTION WITH ONES FROM ANOTHER COMPANY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18311975 ↗
• MalfunctionDec 12, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, AFTER FUSION TO T3-S2, THE TOP NOTCHES IN QUESTION WERE USED FOR KYPHOSIS CORRECTION. THE IMPLANTS COULD NOT WITHSTAND THE ORTHODONTIC FORCES AND MOVED ON THE RODS AFTER THE SET SCREWS WERE FASTENED. THE SURGEON REPLACED ALL THE PRODUCTS IN QUESTION WITH ONES FROM ANOTHER COMPANY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18311973 ↗
• InjuryDec 1, 2023Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2023, THE ROD BECAME DISCONNECTED FROM THE CONNECTOR. DUE TO POSTOPERATIVE LOOSENING OF THE SET SCREW, REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THE PATIENT EXPERIENCED PAIN AS A RESULT OF THE EVENT. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 18245775 ↗

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