EXPEDIUM 179704999Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034265889), received between Feb 5, 2019 and Jul 27, 2026 — classified as 3 injuries, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Difficult to Advance; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50046418 ↗
• InjuryAug 23, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A SURGERY FOR POSTERIOR SPINAL FUSION IN (B)(6) OF 2020. AT A FOLLOW UP APPOINTMENT IN (B)(6) OF 2020, XRAY IMAGES SHOWED THAT THE SET SCREW HAD LOOSENED FROM THE SAI SCREWS BILATERALLY AND THE ROD HAD LOOSENED DUE TO HEAD SPLAY. THE S1 AND L5 SCREWS HAD FRACTURED AT THE NECK OF THE SCREW JUST BELOW THE TULIP. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. THE PATIENT DID NOT ACHIEVE A FUSION BELOW L5 DUE TO THIS HARDWARE FAILURE. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) VIPER TI SAI POLY 9X100MM. THIS REPORT IS 3 OF 5 FOR (B)(4).

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

  MAUDE report 12354169 ↗
• InjuryJun 26, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING REVISION, THE ROD BREAK BOTH SIDES. AFTER CHECKING THE SACRAL ALAR ILIAC (SAI) SCREWS, IT WAS FOUND THAT ONE SCREW DOES NOT HOLD WELL IN THE BONE LIKE THE OTHER AND WAS REPLACED, METALLOSE WERE DETECTED IN THE AREA OF THE REPLACED SCREW. SURGICAL DELAY AND PROCEDURE OUTCOME ARE UNKNOWN. THERE WAS PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8734465 ↗
• InjuryFeb 5, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PELVIC FIXATION SURGERY WAS PERFORMED ON (B)(6). WHEN THE SURGEON INSERTED THE SCREW FROM THE PATIENT'S LEFT SACRUM INTO THE ILIUM, THE SURGEON RECOGNIZED THE STRANGE NOISE, AND THEN FOUND THE BROKEN FRAGMENT (LIKE SCREW THREAD) IN THE SCREW HEAD. THUS, THE SURGEON REMOVED THE BROKEN FRAGMENT. THEN, THE SURGEON ATTEMPTED FINAL TIGHTENING WITH SET SCREW; HOWEVER, THE SET SCREW WAS SPIN IDLED. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE SCREW (P/N AND LOT # WERE UNKNOWN). THERE WAS LESS THAN 30 MIN. SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8307023 ↗