EXPEDIUM VERSE 199723850Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034402758), received between Mar 28, 2019 and Oct 15, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT: SCREWS WERE CHANGED AT LEVELS L2 AND S1, BECAUSE EXPEDIUM SCREWS WERE FENESTRATED, CONFIDENCE CEMENT WAS PLACED ON THE FENESTRATED SCREWS, AT THE TIME OF FINISHING PLACING THE CONFIDENCE CEMENT INSIDE THE SCREWS A CONTROL PLATE WAS TAKEN IN WHERE IT WAS NOTICED THAT THE CEMENT CAME OUT OF THE VERTEBRAL BODY THROUGH THE LOWER HOLE OF THE SCREW AT LEVEL S1. DIAGNOSIS: POST-OPERATED UNSTABLE LUMBAR COLUMN + SCREW EXTRUSION L2-S1 BILATERAL. SURGERY: CHANGE OF BILATERAL L2 AND S1 SCREWS WITH CANNULATED SCREWS AND VERTEBROPLASTY OF THE SAME LEVELS. CODE: 283910000 ; LOT: NOT INFORMED. CODE: 199723850 (02 UNITS) ; LOT: NOT INFORMED. CODE: 199723840 (02 UNITS) ; LOT: NOT INFORMED. CONCOMITANT DEVICE REPORTED: CONFIDENCE SPINAL CEMENT SYSTEM, (PART# 283910000, LOT# UNKNOWN, QUANTITY 1). UNKNOWN PLATE, (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES.

  Patient problems: Tissue Damage

  MAUDE report 9191887 ↗
• InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT: SCREWS WERE CHANGED AT LEVELS L2 AND S1, BECAUSE EXPEDIUM SCREWS WERE FENESTRATED, CONFIDENCE CEMENT WAS PLACED ON THE FENESTRATED SCREWS, AT THE TIME OF FINISHING PLACING THE CONFIDENCE CEMENT INSIDE THE SCREWS A CONTROL PLATE WAS TAKEN IN WHERE IT WAS NOTICED THAT THE CEMENT CAME OUT OF THE VERTEBRAL BODY THROUGH THE LOWER HOLE OF THE SCREW AT LEVEL S1. DIAGNOSIS: POST-OPERATED UNSTABLE LUMBAR COLUMN + SCREW EXTRUSION L2-S1 BILATERAL. SURGERY: CHANGE OF BILATERAL L2 AND S1 SCREWS WITH CANNULATED SCREWS AND VERTEBROPLASTY OF THE SAME LEVELS. CODE: 283910000 ; LOT: NOT INFORMED. CODE: 199723850 (02 UNITS) ; LOT: NOT INFORMED. CODE: 199723840 (02 UNITS) ; LOT: NOT INFORMED. CONCOMITANT DEVICE REPORTED: CONFIDENCE SPINAL CEMENT SYSTEM (PART# 283910000, LOT# UNKNOWN, QUANTITY 1). UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES.

  Patient problems: Tissue Damage

  MAUDE report 9176325 ↗
• InjuryMar 28, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT RETURNED FOR REVISION OF SPINE INSTRUMENTATION DUE TO LEFT SIDE S1 PEDICLE SCREW DISENGAGING FROM ROD. IF OTHER, DESCRIBE. L3-S1 POSTERIOR FUSION WITH ALIF L5S1 AND LATERAL CAGE L3-4. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? YES. IF YES, PLEASE DESCRIBE. LEFT SIDE S1 PEDICLE SCREW DISENGAGING FROM ROD. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? NO. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. WAS DEVICE EXPLANTED? TRUE. DID PATIENT REQUIRE REVISION SURGERY? TRUE. IF YES, DATE OF REVISION SURGERY. ON (B)(6) 2019. PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 8459713 ↗