VIPER 186789200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034132969), received between Oct 31, 2018 and Jun 3, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Break” (6 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2024Break; Break

  IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION PERFORMED ON (B)(6) 2022. AFTER THE SURGERY ON (B)(6) 2024, THE SALES REP WAS INFORMED THAT THE ROD AND SCREW BROKE OFF. ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED. BILATERAL RODS WERE REMOVED AND THE BROKEN SCREW HEADS WERE REMOVED. A VERSE FENESTRATED SCREW WAS INSERTED AT THE,9 AND L3,4 AND BONE CEMENT WAS INJECTED INTO ALL SCREWS. AFTER THE BONE CEMENT HARDENED, RODS WERE PLACED BILATERALLY. UNIVERSAL AND SFX CONNECTORS WERE USED, AND ADDITIONAL RODS WERE PLACED NEAR THE MIDLINE. THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM ROD, STRAIGHT 200MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19449364 ↗
• InjuryAug 13, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021 THE PATIENT UNDERWENT FOR REVISION PROCEDURE (POSTERIOR LUMBAR SPINAL FUSION BETWEEN T10-L3) WAS PERFORMED FOR PURULENT SPONDYLITIS. THE SURGEON PREOPERATIVELY PRESUMED POSSIBLE ROD BREAKAGES. IT WAS ACTUALLY FOUND THAT THE RODS ON BOTH SIDES HAD BROKEN OFF. THE PATIENT OUTCOME WAS UNKNOWN. ON (B)(6) 2018 THE PRIMARY PERCUTANEOUS SPINAL FUSION WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) VIPER2 STRAIGHT ROD-200MM THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: Inflammation

  MAUDE report 12320156 ↗
• InjuryAug 13, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021 THE PATIENT UNDERWENT FOR REVISION PROCEDURE (POSTERIOR LUMBAR SPINAL FUSION BETWEEN T10-L3) WAS PERFORMED FOR PURULENT SPONDYLITIS. THE SURGEON PREOPERATIVELY PRESUMED POSSIBLE ROD BREAKAGES. IT WAS ACTUALLY FOUND THAT THE RODS ON BOTH SIDES HAD BROKEN OFF. THE PATIENT OUTCOME WAS UNKNOWN. ON (B)(6) 2018 THE PRIMARY PERCUTANEOUS SPINAL FUSION WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) VIPER2 STRAIGHT ROD-200MM. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Inflammation

  MAUDE report 12320136 ↗
• InjuryMar 29, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RODS HAD BROKEN SOME TIME AFTER THE PROCEDURE. ON (B)(6) 2018 THE PATIENT UNDERWENT THE PRIMARY PROCEDURE FOR A CENTRUM PLASTY AT L1 AND A POSTERIOR FUSION AT 3A-3B FOR THE TREATMENT OF L1 COMPRESSION FRACTURE. ON (B)(6) 2021 THE TWO RODS WERE FOUND TO BE BROKEN OFF. THE PATIENT IS SCHEDULED FOR A REVISION SURGERY ON (B)(6) 2021, THE RODS WILL BE REPLACED. THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM ROD, STRAIGHT 200MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 11581450 ↗
• InjuryMar 29, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RODS HAD BROKEN SOME TIME AFTER THE PROCEDURE. ON (B)(6) 2018 THE PATIENT UNDERWENT THE PRIMARY PROCEDURE FOR A CENTRUM PLASTY AT L1 AND A POSTERIOR FUSION AT 3A-3B FOR THE TREATMENT OF L1 COMPRESSION FRACTURE. ON (B)(6) 2021 THE TWO RODS WERE FOUND TO BE BROKEN OFF. THE PATIENT IS SCHEDULED FOR A REVISION SURGERY ON (B)(6) 2021, THE RODS WILL BE REPLACED. THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM ROD, STRAIGHT 200MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 11581400 ↗
• InjuryJun 3, 2019Break; Break

  IT WAS REPORTED THAT AN UNKNOWN DATE, THE PATIENT UNDERWENT HARDWARE REMOVAL, THERE WAS A STRAIGHT ROD BREAKAGE AND A LOOSENING OF AN INNER SET SCREW. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8664279 ↗
• InjuryOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 VIA POSTERIOR SPINE FUSION TO FIX TH11-L2 BY USING HA BLOCK (MANUFACTURER WAS PENTAX, P/N AND LOT NUMBER WERE UNKNOWN), SCREWS TO TH11, 12, L1 AND L2, AND SET SCREWS. AFTER THE PRIMARY SURGERY ON UNKNOWN DATE, THE SURGEON RECOGNIZED THAT THE PATIENT SUFFERED THE INFECTION. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2018 TO REMOVE THE RODS, SET SCREWS, AND THE SCREWS AT TH12 AND L1,AND THE IMPLANTED THE NEW SCREWS (P/N AND LOT NUMBER WERE UNKNOWN) TO TH10 AND L3, AND THEN FIX WITH NEW RODS (P/N AND LOT NUMBER WERE UNKNOWN) AT TH10.11.L2.3 USING NEW SET SCREWS (P/N AND LOT NUMBER WERE UNKNOWN). NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8025963 ↗
• InjuryOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 VIA POSTERIOR SPINE FUSION TO FIX TH11-L2 BY USING HA BLOCK (MANUFACTURER WAS PENTAX, P/N AND LOT NUMBER WERE UNKNOWN), SCREWS TO TH11, 12, L1 AND L2, AND SET SCREWS. AFTER THE PRIMARY SURGERY ON UNKNOWN DATE, THE SURGEON RECOGNIZED THAT THE PATIENT SUFFERED THE INFECTION. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2018 TO REMOVE THE RODS, SET SCREWS, AND THE SCREWS AT TH12 AND L1, AND THE IMPLANTED THE NEW SCREWS (P/N AND LOT NUMBER WERE UNKNOWN) TO TH10 AND L3, AND THEN FIX WITH NEW RODS (P/N AND LOT NUMBER WERE UNKNOWN) AT TH10.11.L2.3 USING NEW SET SCREWS (P/N AND LOT NUMBER WERE UNKNOWN). NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8025800 ↗

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