EXPEDIUM 179712640Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705034067728), received between Oct 11, 2017 and Aug 27, 2024 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (9 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 IT WAS NOTED THAT SINCE SURGERY AND EXTUBATION, THE PATIENT'S MENTAL STATUS HAS BEEN ALTERED. INITIALLY (B)(6) THE PATIENT WAS MORE LETHARGIC BUT BY DOCUMENTATION SEEMED TO HAVE A FLUCTUATING LEVEL OF AROUSAL/ALERTNESS AND SOME DISORIENTATION. STARTING (B)(6) AND INTO (B)(6), THE PATIENT HAS HAD PROGRESSIVE WORSENING OF AGITATION, SLEEP DISTURBANCE, AND DISORIENTATION, AS WELL AS NEW HALLUCINATIONS, ILLUSIONS AND DELUSIONS. DURING THIS PERIOD THE PATIENT'S MENTAL STATUS WAS WAXING AND WANING. ON (B)(6) 2020 THE PATIENT WAS RELEASED FROM THE HOSPITAL. ON (B)(6) 2020, X-RAYS WERE TAKEN WHICH SHOWED MULTIPLE THORACIC BURST/COMPRESSION FRACTURES, MOST SEVERE AT T6. ON (B)(6) 2020 THE SURGEON NOTED THAT: SHE DID FAIRLY WELL EARLY ON REGAINING SOME OF HER NEUROLOGIC FUNCTION SHE HAD LOST THROUGH PHYSICAL THERAPY BUT THEN HAD COLLAPSE THROUGH HER MIDTHORACIC SPINE. ON (B)(6), 2020 THE SURGEON NOTED THAT: WE INITIALLY INTERVENED TO STOP THE COLLAPSE OF HER THORACIC FRACTURES BY FUSING HER FROM T3-T9. SHE DID WELL INITIALLY AND THEN QUICKLY HER SOFT TISSUES HAD HER CERVICOTHORACIC JUNCTION FAILED. THIS LEFT US NO CHOICE BUT TO INTERVENE BY FUSING BETWEEN

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Nonunion/Delayed-union Bone Fracture; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem; Vertebral Fracture

  MAUDE report 20077709 ↗
• InjuryJan 8, 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: INSTABILITY, COMPLICATION TIME/INTERVENTION, REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 6 X 40MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 18463021 ↗
• InjuryJan 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  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: IMPLANT FAILURE, NON-UNION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 6 X 40MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18450660 ↗
• InjurySep 15, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED TO REMOVE OSTEOSYNTHESIS MATERIAL OF THE SPINE (EXPEDIUM 5.5 SYSTEM) BECAUSE ONE OF THE SCREWS IMPLANTED IN THE PATIENT BROKE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 6 X 40MM. THIS IS REPORT 8 OF 9 FOR (B)(4).

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

  MAUDE report 15428067 ↗
• InjuryApr 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, THE SCREWS WERE BROKEN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 6 X 40MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 14053145 ↗
• InjuryApr 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, THE SCREWS WERE BROKEN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 6 X 40MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 14053143 ↗
• InjuryJan 26, 2021Adverse 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 ON JANUARY 4, 2021 THAT THE PATIENT REPORTED AN ALLERGY AFTER BEING IMPLANTED WITH THE EXPEDIUM IMPLANTS ON AN UNKNOWN DATE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 6 X 40MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11233957 ↗
• InjuryJan 11, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR A REMOVAL SURGERY DUE TO PSEUDARTHROSIS L4-5 AND PROLONGATION TO S1. L5 SCREWS WERE LOOSE BILATERAL AND REMOVED. NO NEW SCREWS COULD BE USED BECAUSE OF THE LARGE HOLE IN THE PEDICLE. PROLONGATION TO S1 AND ROD INSERTION AND FIXATION L4-S1. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ), UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS COMPLAINT INVOLVES TWO (2) DEVICES THIS REPORT IS FOR (1) SI POLYAXIAL SCREW 6 X 40MM. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11148091 ↗
• InjuryJan 11, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR A REMOVAL SURGERY DUE TO PSEUDARTHROSIS L4-5 AND PROLONGATION TO S1. L5 SCREWS WERE LOOSE BILATERAL AND REMOVED. NO NEW SCREWS COULD BE USED BECAUSE OF THE LARGE HOLE IN THE PEDICLE. PROLONGATION TO S1 AND ROD INSERTION AND FIXATION L4-S1. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ), UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) SI POLYAXIAL SCREW 6 X 40MM. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11148075 ↗
• MalfunctionNov 26, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A 6.0 X 40 PEDICLE SCREW SHAFT BROKE DURING A REVISION PROCEDURE ON (B)(6) 2019. THE SHAFT BROKE AWAY FROM THE HEAD OF THE SCREW AS THE SURGEON WAS ATTEMPTING TO REMOVE IT. THANKFULLY THE SCREW WAS REMOVED USING THE OPERACE REAMER. THE REMOVAL WAS ACHIEVED EASILY. THERE WAS APPROXIMATELY FORTY-FIVE (45) MINUTES SURGICAL DELAY TO REMOVE THE DAMAGED PEDICLE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY. THE REASON FOR THE REVISION WAS FURTHER DEGENERATION OF THE SPINE THERE WERE NO ISSUE WITH THE IMPLANTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9376677 ↗
• InjuryOct 22, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  THIS IS A REPORT OF A REVISION CASE. THE INITIAL SURGERY ON THE PATIENT WAS DONE IN (B)(6) 2019. THE ELONGATION OF THE CONSTRUCT WAS NEEDED DUE TO LOOSENING OF THE SCREWS IMPLANTED IN TH10 VERTEBRAE. BOTH OF THE SCREWS WERE EXPLANTED AND THE CONSTRUCT WAS ELONGATED TO TH7. THE PATIENT HAS PARKINSONS DISEASE. PROCEDURE/SURGERY NAME: POSTERIOR LUMBAR SPINAL CONSTRUCT ELONGATION. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT#UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Code Available; Pain

  MAUDE report 9217686 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A LAMINECTOMY OF T11-L3 DUE TO A FRACTURE AT L1 IS NOW SHOWING SYMPTOMS OF HYPERSENSITIVITY TO THE METAL INSTALLED IN HIS BACK DURING THE FUSION. REPORTEDLY, THE PATIENT IS ALLERGIC TO MOST OTHER METALS SUCH AS TITANIUM HARDWARE, BUT WITH HER SYMPTOMS, THIS SEEMS TO BE MOST LIKELY THE CAUSE. ADDITIONALLY, THE PATIENT WANTS TO OBTAIN A SAMPLE OF THE HARDWARE OR THE SAMPLE OF THE MATERIAL TO VERIFY IF THIS IS POSSIBLY WHAT'S CAUSING THE PROBLEMS. THE PATIENT CAN PROVIDE THE ACTUAL IMPLANT TRACKING SHEET FROM THE HOSPITAL IF NEEDED. THERE WAS NO INFORMATION OF THE SURGICAL DELAY AND PATIENT CONSEQUENCE IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICE

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9109672 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A LAMINECTOMY OF T11-L3 DUE TO A FRACTURE AT L1 IS NOW SHOWING SYMPTOMS OF HYPERSENSITIVITY TO THE METAL INSTALLED IN HIS BACK DURING THE FUSION. REPORTEDLY, THE PATIENT IS ALLERGIC TO MOST OTHER METALS SUCH AS TITANIUM HARDWARE, BUT WITH HER SYMPTOMS, THIS SEEMS TO BE MOST LIKELY THE CAUSE. ADDITIONALLY, THE PATIENT WANTS TO OBTAIN A SAMPLE OF THE HARDWARE OR THE SAMPLE OF THE MATERIAL TO VERIFY IF THIS IS POSSIBLY WHAT'S CAUSING THE PROBLEMS. THE PATIENT CAN PROVIDE THE ACTUAL IMPLANT TRACKING SHEET FROM THE HOSPITAL IF NEEDED. THERE WAS NO INFORMATION OF THE SURGICAL DELAY AND PATIENT CONSEQUENCE IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9109652 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A LAMINECTOMY OF T11-L3 DUE TO A FRACTURE AT L1 IS NOW SHOWING SYMPTOMS OF HYPERSENSITIVITY TO THE METAL INSTALLED IN HIS BACK DURING THE FUSION. REPORTEDLY, THE PATIENT IS ALLERGIC TO MOST OTHER METALS SUCH AS TITANIUM HARDWARE, BUT WITH HER SYMPTOMS, THIS SEEMS TO BE MOST LIKELY THE CAUSE. ADDITIONALLY, THE PATIENT WANTS TO OBTAIN A SAMPLE OF THE HARDWARE OR THE SAMPLE OF THE MATERIAL TO VERIFY IF THIS IS POSSIBLY WHAT'S CAUSING THE PROBLEMS. THE PATIENT CAN PROVIDE THE ACTUAL IMPLANT TRACKING SHEET FROM THE HOSPITAL IF NEEDED. THERE WAS NO INFORMATION OF THE SURGICAL DELAY AND PATIENT CONSEQUENCE IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9109628 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A LAMINECTOMY OF T11-L3 DUE TO A FRACTURE AT L1 IS NOW SHOWING SYMPTOMS OF HYPERSENSITIVITY TO THE METAL INSTALLED IN HIS BACK DURING THE FUSION. REPORTEDLY, THE PATIENT IS ALLERGIC TO MOST OTHER METALS SUCH AS TITANIUM HARDWARE, BUT WITH HER SYMPTOMS, THIS SEEMS TO BE MOST LIKELY THE CAUSE. ADDITIONALLY, THE PATIENT WANTS TO OBTAIN A SAMPLE OF THE HARDWARE OR THE SAMPLE OF THE MATERIAL TO VERIFY IF THIS IS POSSIBLY WHAT'S CAUSING THE PROBLEMS. THE PATIENT CAN PROVIDE THE ACTUAL IMPLANT TRACKING SHEET FROM THE HOSPITAL IF NEEDED. THERE WAS NO INFORMATION OF THE SURGICAL DELAY AND PATIENT CONSEQUENCE IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9109297 ↗
• InjuryAug 27, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AFTER AN UNKNOWN PROCEDURE, THE PATIENT IMPLANTS MIGRATED POSTERIORLY AFTER A FALL. THE PATIENT WENT TO THE CLINIC ON MAY 8 AND NOTIFIED THE SURGEON ABOUT THE FALL WHILE TAKING OUT THE TRASH CANS. UNKNOWN DATE ON THE FALL. THE SURGEON ASSUMED THAT THE CAGE MIGRATED AND HAD A CT SCAN DONE TO CONFIRM. ACCORDING TO THE SURGEON, THE IMPLANTS THAT ARE IN THE PATIENT ARE NOT CONCORDE LIFT BUT WAS POSSIBLY CONCORDE BULLET PROTI. THERE WAS NO REVISION CONFIRMATION AND PATIENT SYMPTOMS ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8934467 ↗
• InjuryAug 26, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AFTER AN UNKNOWN PROCEDURE, THE PATIENT IMPLANTS MIGRATED POSTERIORLY AFTER A FALL. THE PATIENT WENT TO THE CLINIC ON MAY 8 AND NOTIFIED THE SURGEON ABOUT THE FALL WHILE TAKING OUT THE TRASH CANS. UNKNOWN DATE ON THE FALL. THE SURGEON ASSUMED THAT THE CAGE MIGRATED AND HAD A CT SCAN DONE TO CONFIRM. ACCORDING TO THE SURGEON, THE IMPLANTS THAT ARE IN THE PATIENT ARE NOT CONCORDE LIFT BUT WAS POSSIBLY CONCORDE BULLET PROTI. THERE WAS NO REVISION CONFIRMATION AND PATIENT SYMPTOMS ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8931925 ↗
• InjuryAug 20, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL OF A BROKEN SCREW. PATIENT HAD HARDWARE PUT IN ABOUT A YEAR AGO FOR A ONE LEVEL TLIF. PATIENT DID WELL AFTER SURGERY BUT EVENTUALLY HAD A NON UNION AND THIS SCREW BROKE AT L5 BECAUSE OF MICRO MOTION FROM THE NON UNION. PATIENT WAS A LARGE MAN GREATER THAT 250 LBS SO FATIGUE OF SCREW WAS INEVITABLE. SCREW WAS BROKEN IN TWO (2) PIECES BOTH WERE RETRIEVED FROM SURGICAL CITE. TIP OF BONE SCREW WAS RETRIEVED USING TREPHINE BIT AND EASY OUT FROM SYNTHES SCREW REMOVAL SYSTEM NO OTHER COMPLICATIONS FROM PROCEDURE, SCREW WAS RETRIEVED AND REPLACED WITH ANOTHER LARGER DIAMETER SCREW AND BMP WAS USED IN LATERAL GUTTERS TO AIDE IN FUSION. POST OPERATIVE OUTCOME WAS GOOD AND PATIENT WENT HOME AFTER TWO DAYS OF RECOVERY TIME. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8911407 ↗
• InjuryAug 16, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  REVISION FUSION: (B)(6) HOSPITAL, (B)(6) 2019. PRIMARY IMPLANT DATE: (B)(6) 2018. REVISION FOR DISLODGED RODS. SET SCREWS WERE NO LONGER IN SCREW HEADS RIGHT SIDE ROD NO LONGER STABLE CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY ONE). THIS COMPLAINT INVOLVES 11 (ELEVEN) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8902924 ↗
• InjuryAug 16, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  REVISION FUSION: (B)(6), (B)(6) 2019. PRIMARY IMPLANT DATE: (B)(6) 2018. REVISION FOR DISLODGED RODS. SET SCREWS WERE NO LONGER IN SCREW HEADS RIGHT SIDE ROD NO LONGER STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY ONE). THIS COMPLAINT INVOLVES 11 (ELEVEN) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8902544 ↗
• InjurySep 14, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  SLIDING WIRES. DURING THE LUMBAR SURGERY, SLIDING WIRES OCCURRED BEFORE LOCKING THE SCREWS AND NUTS . PLEASE SEE THE ATTACHED PHOTOS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7878021 ↗
• InjuryAug 13, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THIS SURGERY WAS A PLF FROM L4-S1 WITH A TLIF. AT SOME POINT AFTER THE CASE, THE ROD DISENGAGED FROM THE HEAD OF THE SCREW AT L4. THE SET SCREW WAS STILL FULLY ENGAGED IN THE HEAD OF THE SCREW WHERE THE ROD CAME OUT. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION: PATIENT REQUIRED A REVISION SURGERY. ACTION TAKEN FOR PROCEDURE: NO ISSUES DURING THE REVISION. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Spinal Column Injury

  MAUDE report 7777705 ↗
• InjuryAug 13, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THIS SURGERY WAS A PLF FROM L4-S1 WITH A TLIF. AT SOME POINT AFTER THE CASE, THE ROD DISENGAGED FROM THE HEAD OF THE SCREW AT L4. THE SET SCREW WAS STILL FULLY ENGAGED IN THE HEAD OF THE SCREW WHERE THE ROD CAME OUT. PATIENT CONSEQUENCE? :YES. PATIENT CONSEQUENCE DESCRIPTION:PATIENT REQUIRED A REVISION SURGERY. ACTION TAKEN FOR PROCEDURE:NO ISSUES DURING THE REVISION. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Spinal Column Injury

  MAUDE report 7777472 ↗
• InjuryDec 14, 2017Break; Break

  IT WAS REPORTED A REVISION WAS PERFORMED DUE TO BROKEN SCREW.

  Patient problems: Spinal Column Injury

  MAUDE report 7116847 ↗
• InjuryNov 29, 2017Break; Break

  TWO EXPEDIUM SI SCREW HEAD BREAKAGE AT LEVEL S1 (EXACT SIZE OF SCREW UNKNOWN - ACC. TO PICTURES APP. 6 X 40 MM). OCCURED AT UNKNOWN DATE APP. ONE YEAR AFTER INITIAL SURGERY (UNKNWON DATE). SCREW BREAKAGE WAS NOTICED DURING REVISION SURGERY ON (B)(6) 2017. PATIENT CONSEQUENCE: NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT: YES.

  Patient problems: Spinal Column Injury

  MAUDE report 7069464 ↗