VIPER 186788040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034131733), received between Jan 8, 2024 and Jul 11, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (L4, L5) FOR CERVICAL SPINAL CANAL STENOSIS ON (B)(6) 2024. IN THE SURGERY, AFTER THE SCREWS WERE INSERTED AND THE RODS INSTALLED, THE FRONT AND SIDES OF THE IMAGE WERE CHECKED AND THE TABS WERE FOLDED FOR THE FINAL FASTENING. WHEN THE SURGEON DID A FINAL CHECK ON THE IMAGE BEFORE CLOSING, THE SCREWS IN QUESTION HAD TO BE REINSERTED. THE LEFT SET SCREW AND THE ROD IN QUESTION WERE REMOVED, AND THE L4 AND L5 SCREWS WERE EXTRACTED AND REINSERTED. VIPER PRIME USED A NEW SCREW BECAUSE THERE IS NO SCREWDRIVER THAT CAN INSERT A SCREW WITHOUT A TAB. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM ROD, PRE-LORDOSED 40MM THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720597 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: ADJACENT SEGMENT PATHOLOGY. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VIPER /OTHER AND VIPER CFX FENESTRATED PRODUCTS (VIPER2 LORDOTIC ROD-40MM (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18463555 ↗

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