EXPEDIUM 179762480Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 10705034077437), received between Aug 18, 2017 and Oct 21, 2025 — classified as 102 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (75 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION FOR A METASTATIC SPINAL TUMORS ON (B)(6) 2025. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, IT WAS CONFIRMED THAT THE ROD BROKE. THE ROD BROKE CRANIALLY ON THE LEFT L4. REVISION SURGERY TOOK PLACE ON (B)(6) 2025. A FOUR-ROD CONSTRUCT WAS SUCCESSFULLY CONSTRUCTED USING FOUR TOP NOTCH UNIVERSAL CONNECTOR PIECES, ONE SFX CROSS CONNECTOR PIECE, ONE SFX CROSS CONNECTOR PIECE, AND ONE ROD DIAMETE PIECE. PREOPERATIVE FRONTAL, PREOPERATIVE LATERAL, AND POSTOPERATIVE FRONTAL IMAGES WERE TAKEN. THE SURGEON COMMENTED THAT THE PATIENT SUFFERED FROM METASTATIC SPINAL TUMORS, AND IT IS BELIEVED THAT THE FRACTURE OF THIS PRODUCT OCCURRED DUE TO THE WEAKENING OF BONES CAUSED BY THE METASTATIC TUMORS. THE DOCTOR IN CHARGE HAS DETERMINED THAT THERE IS NO CAUSAL RELATIONSHIP BETWEEN THE HEALTH DAMAGE AND THIS PRODUCT.

  Patient problems: Solid Tumor

  MAUDE report 23349720 ↗
• InjuryOct 23, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (T7-S2) WAS PERFORMED ON (B)(6) 2021, WITH RODS. AFTER SURGERY, THE RODS WERE FOUND TO BE BROKEN. ON (B)(6) 2024. REVISION SURGERY WAS PERFORMED. THE SURGEON DID NOT REMOVE THE BROKEN RODS BUT LEFT THEM IN PLACE AND CONNECTED THEM USING CONNECTORS. THEREFORE, THE BROKEN RODS WERE RETAINED IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20515448 ↗
• InjuryOct 23, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (T7-S2) WAS PERFORMED ON (B)(6) 2021, WITH RODS. AFTER SURGERY, THE RODS WERE FOUND TO BE BROKEN. ON (B)(6) 2024. REVISION SURGERY WAS PERFORMED. THE SURGEON DID NOT REMOVE THE BROKEN RODS BUT LEFT THEM IN PLACE AND CONNECTED THEM USING CONNECTORS. THEREFORE, THE BROKEN RODS WERE RETAINED IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20515395 ↗
• InjuryOct 23, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (T7-S2) WAS PERFORMED ON (B)(6) 2021, WITH RODS. AFTER SURGERY, THE RODS WERE FOUND TO BE BROKEN. ON (B)(6) 2024. REVISION SURGERY WAS PERFORMED. THE SURGEON DID NOT REMOVE THE BROKEN RODS BUT LEFT THEM IN PLACE AND CONNECTED THEM USING CONNECTORS. THEREFORE, THE BROKEN RODS WERE RETAINED IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20515367 ↗
• InjuryAug 28, 2024Migration; Migration

  IT WAS REPORTED THROUGH LEGAL DOCUMENTATION, THE PATIENT SUSTAINED INJURIES DUE TO A CAR ACCIDENT ON (B)(6) 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 TH

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

  MAUDE report 20088950 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LEGAL DOCUMENTATION, THE PATIENT SUSTAINED INJURIES DUE TO A CAR ACCIDENT ON (B)(6) 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 ¿[I]NSTRUMENTED 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

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 20086315 ↗
• InjuryAug 15, 2024Break; Break

  IT WAS REPORTED THAT A POSTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED ON (B)(6) 2017. AFTER THE SURGERY, REOPERATIONS FOR EXTENSION HAVE BEEN PERFORMED AS FOLLOWS: A SECOND SURGERY WAS PERFORMED ON (B)(6) 2017 FOR EXTENSION (TH12-). A THIRD SURGERY WAS PERFORMED ON (B)(6) 2017 ON TH11-L5. A FOURTH SURGERY WAS PERFORMED ON (B)(6) 2021 ON TH5-TH7 WITH THE ROD IN QUESTION. ON JULY 18, 2024, THE SURGEON INFORMED THAT A FIFTH SURGERY WAS PLANNED FOR (B)(6) 2024 DUE TO ROD BREAKAGE. THE PLAN WAS TO REMOVE THE EXPEDIUM ROD AND REPLACE WITH ANOTHER ROD (5.5 TITANIUM AND COBALT CHROME). THE PATIENT STATUS WAS REPORTED TO BE STABLE. THERE WAS NO SURGICAL DELAY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19996530 ↗
• InjuryApr 3, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN POLAND AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS OPERATED ON IN (B)(6) 2020 IN MID-FEBRUARY THIS YEAR SHE CAME TO US WITH PAIN IN THE OPERATED AREA. A BROKEN ROD HAS BEEN FOUND IN THE X-RAY. THIS REPORT IS FOR ONE (1) ROD, 480 MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 19032750 ↗
• MalfunctionFeb 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES IN QUESTION WERE RECEIVED AS PART OF A BLIND UNIT AND WERE DISCOVERED TO BE BROKEN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18730989 ↗
• MalfunctionFeb 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES IN QUESTION WERE RECEIVED AS PART OF A BLIND UNIT AND WERE DISCOVERED TO BE BROKEN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18730983 ↗
• 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: ADJACENT SEGMENT PATHOLOGY, NON-UNION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND EXPEDIUM POLYAXIAL PRODUCTS (ROD, 480 MM (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Osteolysis

  MAUDE report 18455223 ↗
• 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: NON-UNION, SPINAL IMBALANCE COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: Joint Laxity; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18452466 ↗
• 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: WOUND HEALING PROBLEM, COMPLICATION TIME/INTERVENTION, REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 18451000 ↗
• InjuryJan 4, 2024Migration; Migration

  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, IMPLANT FAILURE, POSTOPERATIVE INFECTION DEEP, WOUND HEALING PROBLEM. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND EXPEDIUM POLYAXIAL AND VIPER CFX FENESTRATED PRODUCTS (ROD, 480 MM FOR (B)(4).

  Patient problems: Impaired Healing; Insufficient Information; Osteolysis; Unspecified Infection

  MAUDE report 18443424 ↗
• InjuryJan 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  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, IMPLANT FAILURE, COMPLICATION TIME/INTERVENTION, AND REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND EXPEDIUM POLYAXIAL PRODUCTS (ROD, 480 MM) FOR (B)(4).

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 18443013 ↗
• InjuryDec 26, 2023Break; Break

  THE PATIENT OUTCOME WAS REPORTED TO BE STABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 18394879 ↗
• InjuryDec 26, 2023Break; Break

  THE PATIENT OUTCOME WAS REPORTED TO BE STABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 18394874 ↗
• InjurySep 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT REPORTED IN (B)(4) IS SCHEDULED TO UNDERGO REVISION SURGERY AGAIN. THE PATIENT UNDERWENT THE 1ST REVISION SURGERY VIA SPINAL FUSION ON (B)(4) 2022, AND IT WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE 1ST REVISION SURGERY, BREAKAGE OF THE RODS OCCURRED. THE SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, AS SCHEDULED. REGARDING THE RIGHT SIDE, THE RODS WERE BROKEN OFF AT A CRANIAL SIDE OF T10, AND REGARDING THE LEFT SIDE, THE RODS WERE BROKEN OFF AT A CRANIAL SIDE OF T11. THE BROKEN RODS, EXPEDIUM CFS SCREWS, SFX CROSS CONNECTORS, ROD CONNECTORS, AND TOP-NOTCH UNIVERSAL CONNECTORS, ETC. WERE REMOVED, AND A FIXATION (T1-L2) WAS DONE. THE SECOND REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON COMMENTED THAT THE CAUSE OF THE BREAKAGE OF THE RODS THIS TIME WAS DUE TO NON-UNION, AND THAT THE EVENT WAS NO PRODUCT RELATED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) UNKNOWN RODS THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17798610 ↗
• InjurySep 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT REPORTED IN (B)(4) IS SCHEDULED TO UNDERGO REVISION SURGERY AGAIN. THE PATIENT UNDERWENT THE 1ST REVISION SURGERY VIA SPINAL FUSION ON (B)(6) 2022, AND IT WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE 1ST REVISION SURGERY, BREAKAGE OF THE RODS OCCURRED. THE SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, AS SCHEDULED. REGARDING THE RIGHT SIDE, THE RODS WERE BROKEN OFF AT A CRANIAL SIDE OF T10, AND REGARDING THE LEFT SIDE, THE RODS WERE BROKEN OFF AT A CRANIAL SIDE OF T11. THE BROKEN RODS, EXPEDIUM CFS SCREWS, SFX CROSS CONNECTORS, ROD CONNECTORS, AND TOP-NOTCH UNIVERSAL CONNECTORS, ETC. WERE REMOVED, AND A FIXATION (T1-L2) WAS DONE. THE SECOND REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON COMMENTED THAT THE CAUSE OF THE BREAKAGE OF THE RODS THIS TIME WAS DUE TO NON-UNION, AND THAT THE EVENT WAS NO PRODUCT RELATED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) UNKNOWN RODS. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17798607 ↗
• InjurySep 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT REPORTED IN (B)(4) IS SCHEDULED TO UNDERGO REVISION SURGERY AGAIN. THE PATIENT UNDERWENT THE 1ST REVISION SURGERY VIA SPINAL FUSION ON (B)(6) 2022, AND IT WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE 1ST REVISION SURGERY, BREAKAGE OF THE RODS OCCURRED. THE SECOND REVISION SURGERY WAS PERFORMED ON SEPTEMBER 5, 2023, AS SCHEDULED. REGARDING THE RIGHT SIDE, THE RODS WERE BROKEN OFF AT A CRANIAL SIDE OF T10, AND REGARDING THE LEFT SIDE, THE RODS WERE BROKEN OFF AT A CRANIAL SIDE OF T11. THE BROKEN RODS, EXPEDIUM CFS SCREWS, SFX CROSS CONNECTORS, ROD CONNECTORS, AND TOP-NOTCH UNIVERSAL CONNECTORS, ETC. WERE REMOVED, AND A FIXATION (T1-L2) WAS DONE. THE SECOND REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON COMMENTED THAT THE CAUSE OF THE BREAKAGE OF THE RODS THIS TIME WAS DUE TO NON-UNION, AND THAT THE EVENT WAS NO PRODUCT RELATED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ROD, 480 MM. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17798601 ↗
• InjurySep 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT REPORTED IN (B)(4) IS SCHEDULED TO UNDERGO REVISION SURGERY AGAIN. THE PATIENT UNDERWENT THE 1ST REVISION SURGERY VIA SPINAL FUSION ON (B)(6), 2022, AND IT WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE 1ST REVISION SURGERY, BREAKAGE OF THE RODS OCCURRED. THE SECOND REVISION SURGERY WAS PERFORMED ON (B)(6), 2023, AS SCHEDULED. REGARDING THE RIGHT SIDE, THE RODS WERE BROKEN OFF AT A CRANIAL SIDE OF T10, AND REGARDING THE LEFT SIDE, THE RODS WERE BROKEN OFF AT A CRANIAL SIDE OF T11. THE BROKEN RODS, EXPEDIUM CFS SCREWS, SFX CROSS CONNECTORS, ROD CONNECTORS, AND TOP-NOTCH UNIVERSAL CONNECTORS, ETC. WERE REMOVED, AND A FIXATION (T1-L2) WAS DONE. THE SECOND REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON COMMENTED THAT THE CAUSE OF THE BREAKAGE OF THE RODS THIS TIME WAS DUE TO NON-UNION, AND THAT THE EVENT WAS NO PRODUCT RELATED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ROD, 480 MM. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17798600 ↗
• InjurySep 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT REPORTED IN (B)(4) IS SCHEDULED TO UNDERGO REVISION SURGERY AGAIN. THE PATIENT UNDERWENT THE 1ST REVISION SURGERY VIA SPINAL FUSION ON (B)(6) 2022, AND IT WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE 1ST REVISION SURGERY, BREAKAGE OF THE RODS OCCURRED. THE SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, AS SCHEDULED. REGARDING THE RIGHT SIDE, THE RODS WERE BROKEN OFF AT A CRANIAL SIDE OF T10, AND REGARDING THE LEFT SIDE, THE RODS WERE BROKEN OFF AT A CRANIAL SIDE OF T11. THE BROKEN RODS, EXPEDIUM CFS SCREWS, SFX CROSS CONNECTORS, ROD CONNECTORS, AND TOP-NOTCH UNIVERSAL CONNECTORS, ETC. WERE REMOVED, AND A FIXATION (T1-L2) WAS DONE. THE SECOND REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON COMMENTED THAT THE CAUSE OF THE BREAKAGE OF THE RODS THIS TIME WAS DUE TO NON-UNION, AND THAT THE EVENT WAS NOT PRODUCT RELATED. THIS REPORT IS FOR ONE (1) ROD, 480 MM THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17798599 ↗
• InjurySep 18, 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 THIS WAS A PSF (T9-L1) PERFORMED ON (B)(6) 2014. AFTER SURGERY, A PRESSURE ULCER WAS OBSERVED AT THE UPPER END OF T9. IC WAS HELD BETWEEN THE SURGEON AND THE PATIENT TO CONFIRM WHETHER TO REMOVE ONLY THE ROD AT THE AFFECTED SITE OR TO REMOVE ALL THE IMPLANTS. IT WAS DETERMINED TO REMOVE ALL IMPLANTS. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2023, AS SCHEDULED. ALL THE IMPLANTS WERE REMOVED WITHOUT ANY PROBLEMS, AND THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) ROD, 480 MM. THIS IS REPORT 10 OF 10 FOR COMPLAINT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 17763922 ↗
• MalfunctionJun 26, 2023Break; Break

  DEVICE REPORT FROM MALAYSIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING THE FINAL STEP OF A SCOLIOSIS SURGERY ON (B)(6) 2023, THE SURGEON INPUT THE CROSSLINKS. UPON THE FINAL TIGHTENING OF THE CROSSLINKS NUTS, THE TIP OF THE INSTRUMENT SHAFT ATTACHED TO THE TORQUE LIMITER HANDLE BROKE OFF. THE FRAGMENT OF THE INSTRUMENT SHAFT WAS STUCK INSIDE THE CROSSLINK NUT RECESS. AS THE IMPLANT WOULD BE VERY DIFFICULT TO REMOVE IN ANY FUTURE SURGERY, THE SURGEON DECIDED TO CHANGE THE CROSSLINK FOR THIS PATIENT. BEFORE IMPLANTING IT IN, THE SURGEON TESTED THE FINAL TIGHTENING MECHANISM OUTSIDE OF THE PATIENT'S BODY. THE RESULT WAS THAT THE OTHER INSTRUMENT SHAFT ALSO BROKE OFF AT THE TIP. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWENTY MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A ROD, 480 MM THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17203600 ↗
• InjuryMar 10, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE ON (B)(6) 2019. THE SURGEON PERFORMED A SECOND SURGERY ON (B)(6) 2020. AFTER THE SURGERIES, ROD BREAKAGE WAS CONFIRMED ON AN UNKNOWN DATE. THE RODS WERE BROKEN ON BOTH SIDES BETWEEN L4 AND L5. THEREFORE, A THIRD SURGERY WAS PERFORMED. ON THE LEFT SIDE, THE BROKEN ROD WAS REPLACED WITH A NEW TITANIUM ROD AND WAS CONNECTED AND REINFORCED USING A TOP NOTCH UNIVERSAL CONNECTOR AND ROD CONNECTOR. ON THE RIGHT SIDE, THE BROKEN ROD WAS LEFT IN PLACE, AND A NEW TITANIUM ROD AND TOP NOTCH UNIVERSAL CONNECTER WERE USED TO CONNECT AND REINFORCE THE ROD. THE THIRD SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16522787 ↗