VIPER 186788080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034131818), received between Jan 15, 2020 and Jan 9, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED AN UNKNOWN SPINE SURGERY OCCURRED ON (B)(6) 2018. POST OPERATIVELY, THE EXTENDED RE-FUSION SURGERY WILL BE PERFORMED DUE TO THE ADJACENT INTERVERTEBRAL DISORDERS. IT IS CONFIRMED L4/5 ACHIEVED OSTEOSYNTHESIS. THE PLAN IS TLIF FOR L2/3, AND L5 MIGHT BE REMOVED DEPENDING ON INTRAOPERATIVE DECISION. NO FURTHER INFORMATION IS AVAILABLE. (B)(4) ARE LINKED TO (B)(4). (B)(4) (DEPUY SPINE): SCREWS. (B)(4) (SYNTHES SPINE): CAGES. THIS REPORT IS FOR ONE VIPER 2 SYSTEM ROD, PRE-LORDOSED 80MM FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18475830 ↗
• InjuryJan 8, 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: IMPLANT FAILURE, IMPLANT MALPOSITION, OTHER. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM ROD, PRE-LORDOSED 80MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18463512 ↗
• 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 BENEDRYL 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 MINISCULE. 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 9590965 ↗

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