EXPEDIUM 179712645Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705034067735), received between Sep 18, 2017 and Oct 31, 2025 — classified as 30 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Break; Break

  IT WAS REPORTED THE PATIENT UNDERWENT THE ORIGINAL PROCEDURE IN 2023. SINCE THEN IT WAS NOTED THE SCREW IS CRACKED AND PATIENT NEEDS TO UNDERGO A REVISION PROCEDURE TO CORRECT IT.

  Patient problems: Insufficient Information

  MAUDE report 23437826 ↗
• InjuryAug 5, 2025Migration; Migration

  IT WAS REPORTED THE PATIENT UNDERWENT POSTERIOR LUMBAR L4-5 LAMINECTOMY AND SPINAL CANAL DECOMPRESSION. POSTOPERATIVELY, THE SCREW MIGRATED. THE PATIENT UNDERWENT A SECOND SURGERY TO ADJUST THE SCREW POSITION.

  Patient problems: Insufficient Information

  MAUDE report 22715721 ↗
• MalfunctionMay 8, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE DISTRIBUTION CENTER HAS NOTICED THAT RECEIVED PRODUCTS WITH LABEL DIFFERENT THEN PREVIOUS TIME. TWO PRODUCTS WERE SENT TO CUSTOMER BEFORE POTENTIAL ISSUE WAS DISCOVERED.

  Patient problems: Insufficient Information

  MAUDE report 21988262 ↗
• InjuryJan 5, 2024Migration; Migration

  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 MALPOSITION, INSTABILITY, NON-UNION, POSTOPERATIVE INFECTION DEEP, COMPLICATION TIME/INTERVENTION. REPEAT SURGERY, THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND EXPEDIUM POLYAXIAL PRODUCTS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; Joint Laxity; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 18453299 ↗
• InjuryJan 5, 2024Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  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: HARDWARE REMOVAL, IMPLANT FAILURE, IMPLANT MALPOSITION, COMPLICATION TIME/INTERVENTION, AND REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 6 X 45MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18451477 ↗
• 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 45MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

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

  MAUDE report 18450638 ↗
• InjuryJan 5, 2024Migration; Migration

  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: FAILURE TO REACH THERAPEUTIC GOALS, IMPLANT FAILURE, IMPLANT MALPOSITION, INSTABILITY, COMPLICATION TIME/INTERVENTION. REPEAT SURGERY, THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 6 X 45MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 18450187 ↗
• InjuryJul 21, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED TO EXTEND THE CONSTRUCT UP. UPON OPENING, IT WAS NOTICED THAT METALLOSIS HAD OCCURRED. THE HEADS OF THE PEDICLE SCREWS AT T11 AND T12 ON THE RIGHT HAD DISLODGED AND BROKEN OFF OF THE SCREWS. IT WAS ALSO OCCURRED WITH THE LEFT SACRAL SCREW. THE PREVIOUS CONSTRUCT WAS FROM T10-PELVIS. THIS REPORT IS FOR ONE (1) SI POLYAXIAL SCREW 5.5 X 6 X 45MM. THIS IS REPORT 6 OF 6 FOR (B)(4).

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

  MAUDE report 12205117 ↗
• InjuryJul 21, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED TO EXTEND THE CONSTRUCT UP. UPON OPENING, IT WAS NOTICED THAT METALLOSIS HAD OCCURRED. THE HEADS OF THE PEDICLE SCREWS AT T11 AND T12 ON THE RIGHT HAD DISLODGED AND BROKEN OFF OF THE SCREWS. IT WAS ALSO OCCURRED WITH THE LEFT SACRAL SCREW. THE PREVIOUS CONSTRUCT WAS FROM T10-PELVIS. THIS REPORT IS FOR ONE (1) SI POLYAXIAL SCREW 5.5 X 6 X 45MM. THIS IS REPORT 1 OF 6 FOR (B)(4).

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

  MAUDE report 12204953 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT EXPERIENCED FRACTURE OF THE POSTERIOR 1/3 OF THE L1 VERTEBRAL BODY AFTER BEING IMPLANTED WITH EXPEDIUM SCREWS. THIS REPORT IS FOR AN EXPEDIUM SINGLE INNER POLYAXIAL SCREW. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Vertebral Fracture

  MAUDE report 11314046 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT EXPERIENCED FRACTURE OF THE POSTERIOR 1/3 OF THE L1 VERTEBRAL BODY AFTER BEING IMPLANTED WITH EXPEDIUM SCREWS. THIS REPORT IS FOR AN EXPEDIUM SINGLE INNER POLYAXIAL SCREW. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Vertebral Fracture

  MAUDE report 11314045 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT EXPERIENCED FRACTURE OF THE POSTERIOR 1/3 OF THE L1 VERTEBRAL BODY AFTER BEING IMPLANTED WITH EXPEDIUM SCREWS. THIS REPORT IS FOR AN EXPEDIUM SINGLE INNER POLYAXIAL SCREW. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: Vertebral Fracture

  MAUDE report 11314012 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT EXPERIENCED FRACTURE OF THE POSTERIOR 1/3 OF THE L1 VERTEBRAL BODY AFTER BEING IMPLANTED WITH EXPEDIUM SCREWS. THIS REPORT IS FOR AN EXPEDIUM SINGLE INNER POLYAXIAL SCREW. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: Vertebral Fracture

  MAUDE report 11313956 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT EXPERIENCED FRACTURE OF THE POSTERIOR 1/3 OF THE L1 VERTEBRAL BODY AFTER BEING IMPLANTED WITH EXPEDIUM SCREWS. THIS REPORT IS FOR AN EXPEDIUM SINGLE INNER POLYAXIAL SCREW. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: Vertebral Fracture

  MAUDE report 11313921 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT EXPERIENCED FRACTURE OF THE POSTERIOR 1/3 OF THE L1 VERTEBRAL BODY AFTER BEING IMPLANTED WITH EXPEDIUM SCREWS. THIS REPORT IS FOR AN EXPEDIUM SINGLE INNER POLYAXIAL SCREW. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Vertebral Fracture

  MAUDE report 11313888 ↗
• InjuryNov 19, 2020Material Twisted/Bent; Unintended Movement; Material Twisted/Bent; Unintended Movement

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SET SCREW FROM THE RIGHT L4 SCREW ¿POPPED-OFF¿ DURING AN UNKNOWN PROCEDURE. REVISION SURGERY WAS REQUIRED. THE SURGEON REMOVED THE REMAINING TWO SET SCREWS AT L5/S1, ROD, AND L4 SCREW. NO FURTHER INFORMATION WAS PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). UNKNOWN RODS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 6 X 45MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10869182 ↗
• 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 9217701 ↗
• 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 9109920 ↗
• 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 9109771 ↗
• 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) DEVICES.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9109701 ↗
• 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 9109324 ↗
• 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 8934438 ↗
• 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 8934403 ↗
• 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 8932110 ↗
• 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 8931646 ↗