VIPER 186788090Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034131832), received between Jan 15, 2020 and Jul 16, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K071860, K111136); they may or may not involve this specific model.

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

• InjuryJul 16, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT THIS WAS A POSTERIOR SPINAL FUSION (L2) PERFORMED ON (B)(6) 2023, WITH VBS+VERSE. THREE MONTHS AFTER SURGERY, IT WAS INSTALLED WITHOUT PROBLEMS. SIX MONTHS POSTOPERATIVELY, BREAKAGE OF THE SCREW IN QUESTION AND LOOSENING OF THE CONTRALATERAL SET SCREW WERE OBSERVED. ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED TO REMOVE THE SCREW AND THE SET SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR ONE (1) VIPER2 LORDOTIC ROD-90MM THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19755393 ↗
• MalfunctionSep 17, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A L4-5-S1 POSTERIOR STABILIZATION/FUSION, A MINIMALLY INVASIVE PROCEDURE, THE SMALL CONNECTING PIECE ON THE VIPER2 ROD BROKE. THE SMALL CONNECTING PIECE BROKE DUE TO THE PRESSURE BEING PLACED ON THE DEVICE. THE BROKEN FRAGMENT WAS HELD IN THE ROD. THE ROD AND THE FRACTURED PIECE WERE EASILY REMOVED. ANOTHER ROD WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CONSEQUENCES TO THE PATIENT. CONCOMITANT DEVICE REPORTED: ROD HOLDER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM ROD, PRE-LORDOSED 90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10545920 ↗
• InjuryJan 15, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD SPINAL FUSION SURGERY. IMMEDIATELY AFTER THE SURGERY THE PATIENT FELT GOOD, BUT ONE WEEK AFTER, THE PATIENT WAS AT THE EMERGENCY ROOM WITH AN ALLERGIC REACTION. HE WAS GIVEN BENADRYL AND SYMPTOMS IMPROVED. HIS CONDITION HAS DETERIORATED AND IN PAIN EVERY DAY. HE HAD A PRIOR SURGERY IN THE 1990S WHERE STAINLESS STEEL OR TITANIUM RODS AND SCREWS WERE IMPLANTED IN HIS HAND AND HAD TO BE REMOVED BECAUSE OF ALLERGIC REACTION THAT CAUSED THE SURGERY SITE NOT TO HEAL. UPON REMOVAL OF THE IMPLANTS, THE HAND HEALED. THE CURRENT SURGEON WAS NOTIFIED OF THE ISSUE WITH THE PRIOR SURGERY BUT INSISTED THAT MATERIALS HAD CHANGED SINCE THE 1990S AND THE POSSIBILITY OF AN ADVERSE REACTION WERE MINUSCULE. BECAUSE OF THE PATIENT URGED THE SURGEON TO GET HIM ALLERGY TESTED BECAUSE OF HOW HE FEELS, HE DID PUT IN AN ORDER AND WAS TESTED, HOWEVER, UPON COMPLETION OF THE TESTING HE WAS TOLD HE WAS TESTED FOR THE WRONG ITEMS. THE PATIENT HAVE NOT HEARD BACK FROM ANYONE AND NOW TAKING HIS HEALTHCARE INTO HIS OWN HANDS AND WOULD LIKE TO HAVE INDEPENDENT ALLERGY TESTING PERFORMED. THE PATIENT NEEDS INFORMATION FROM THE COMPANY IN ORDER TO DO SO. THIS IS REP

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 9590975 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071860, K111136. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2015 · Apr 21, 2015 · Terminated
  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467