EXPEDIUM TOP NOTCH 179771555Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10705034077819), received between Mar 29, 2018 and Jan 27, 2026 — classified as 20 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (10 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. 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 25 most recent of 41 reports, 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 ↗
• MalfunctionFeb 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED DUE TO ROD BREAKAGE. DURING THE SURGERY, RODS WERE ADDED FROM TWO TO FOUR. WHILE APPLYING THE RODS TO THE UNIVERSAL CONNECTOR, THE RODS WERE NOT PARALLEL TO EACH OTHER, AND THE RODS WERE FORCEFULLY INSERTED INTO THE CONNECTOR AT A SLIGHT ANGLE. AFTER TIGHTENING THE SET SCREW WITH A SCREWDRIVER, THE SURGEON FELT DISCOMFORT DURING FINAL TIGHTENING AND LOOSENED THE SET SCREW. THEN, IT WAS FOUND THAT THE SET SCREW THREAD GOT STRIPPED. THE SURGEON CONFIRMED THAT THERE WERE NO METAL FRAGMENTS IN THE PATIENT¿S BODY. A NEW CONNECTOR WAS USED, AND THE RODS WERE BENT TO RE-ARRANGE THE ROD ARRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS PC IS RELATED TO PC-001248342 WHICH REPORTS THAT ROD BROKE AFTER THE PRIMARY SURGERY. THIS PC REPORTS THAT ATTACHING FAILURE OCCURRED DURING THE REVISION SURGERY THIS REPORT INVOLVES ONE UNKNOWN LOCKING/SET SCREWS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436657 ↗
• InjuryFeb 10, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: AS DESCRIBED IN (B)(4), THE PATIENT UNDERWENT THE 1ST REVISION PROCEDURE ON (B)(6) 2021, WITH BOTH THE CONNECTOR AND THE SETSCREW IN QUESTION WHICH WERE DEPLOYED. ON AN UNKNOWN DATE, IT WAS FOUND THAT THE SETSCREW HAD BEEN LOOSE. ON (B)(6), THE PATIENT WAS SCHEDULED TO UNDERGO ANOTHER REVISION PROCEDURE FOR THE SETSCREW REPLACEMENT. THE SURGEON COMMENTED THAT THE SETSCREW IN QUESTION WAS TIGHTENED FOR SURE IN THE 1ST REVISION PROCEDURE. THIS (B)(4) AND (B)(4) ARE RELATED AS FOLLOWS: 1. (B)(4): ABOUT THE LOOSE SETSCREW WHICH WAS DEPLOYED IN THE 1ST REVISION PROCEDURE ON (B)(6) 2021. 2. (B)(4): ABOUT THE ROD BREAKAGE AFTER THE PRIMARY PROCEDURE. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

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

  MAUDE report 13505663 ↗
• InjuryJan 3, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: AS DESCRIBED IN (B)(4), THE PATIENT UNDERWENT THE 1ST REVISION PROCEDURE ON (B)(6) 2021, WITH BOTH THE CONNECTOR AND THE SETSCREW IN QUESTION WHICH WERE DEPLOYED. ON AN UNKNOWN DATE, IT WAS FOUND THAT THE SETSCREW HAD BEEN LOOSE. ON (B)(6), THE PATIENT WAS SCHEDULED TO UNDERGO ANOTHER REVISION PROCEDURE FOR THE SETSCREW REPLACEMENT. THE SURGEON COMMENTED THAT THE SETSCREW IN QUESTION WAS TIGHTENED FOR SURE IN THE 1ST REVISION PROCEDURE. THIS (B)(4) ARE RELATED AS FOLLOWS: (B)(4): ABOUT THE LOOSE SETSCREW WHICH WAS DEPLOYED IN THE 1ST REVISION PROCEDURE ON (B)(6) 2021. (B)(4): ABOUT THE ROD BREAKAGE AFTER THE PRIMARY PROCEDURE. THIS REPORT IS FOR ONE (1) CONN O/O SD TOP NTCH 5.5X5.5 T. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 13146210 ↗
• MalfunctionDec 29, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN PRIMARY PROCEDURE. A NON J&J¿S ROD WAS APPLIED. ON DEC. 1, THE PATIENT UNDERWENT THE REVISION PROCEDURE FOR THE BROKEN-OFF ROD (NON J&J¿S). AFTER THE ROD WAS REPLACED, THE CONNECTOR BROKE DURING SETSCREW TIGHTENING. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT. THE PATIENT OUTCOME WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114443 ↗
• MalfunctionApr 27, 2021Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11733831 ↗
• InjuryDec 7, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE UNIVERSAL CONNECTOR SET WAS RECEIVED WITH THE INCORRECT IMPLANTS CONTAINED IN THE SET. INSTEAD OF FOUR, THERE WERE ONLY TWO CONTAINED IN THE SET. THE SURGEON HAD TO USE A COMPETITOR PRODUCT TO ENSURE THAT THE PROCEDURE WAS COMPLETED. THERE WAS A SURGICAL DELAY OF TWO MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPETED. THIS REPORT IS FOR ONE (1) 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960216 ↗
• InjuryDec 7, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE UNIVERSAL CONNECTOR SET WAS RECEIVED WITH THE INCORRECT IMPLANTS CONTAINED IN THE SET. INSTEAD OF FOUR, THERE WERE ONLY TWO CONTAINED IN THE SET. THE SURGEON HAD TO USE A COMPETITOR PRODUCT TO ENSURE THAT THE PROCEDURE WAS COMPLETED. THERE WAS A SURGICAL DELAY OF TWO MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPETED. THIS REPORT IS FOR ONE (1) 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960186 ↗
• MalfunctionAug 31, 2020Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE THAT THE SMALL SCREW AT THE CONNECTOR, WHICH IS USED TO FIXATE THE RODS, COULD BE TURNED. THERE WAS NO REPORTED SURGICAL DELAY. THERE WAS NO ADVERSE HARM TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER EXP CONNECTOR INSTRUMENT. CONCOMITANT DEVICE REPORTED: RODS (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10471045 ↗
• MalfunctionDec 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION THAT THE LOCKING SCREW HAS COME AWAY FROM THE INSTRUMENT. MAKING IT UNUSABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS COMPLAINT INVOLVES ONE (1) DEVICE THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9416944 ↗
• MalfunctionNov 1, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  DR (B)(6), EXPEDIUM SI SET SCREWS ¿ 186715000, OPEN-CLOSED CONNECTOR - 179755155: REPEATEDLY STRIPPING. PROCEDURE WAS COMPLETED BY USING MULTIPLE LOCKING SCREWS. NO PATIENT COMPLICATIONS. OPERATION WAS COMPLETED AS EXPECTED. 15 MINUTE DELAY TO THE PROCEDURE.

  Patient problems: Not Applicable

  MAUDE report 9265578 ↗

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