VIPER 186789480Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705034133522), received between Feb 27, 2019 and Sep 13, 2024 — classified as 17 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2024Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED STATES THAT PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211211 ↗
• MalfunctionFeb 2, 2024Break; Entrapment of Device; Break; Entrapment of Device

  THERE HAS NOT BEEN A REVISION OR A REMOVAL-SURGERY. THERE WERE NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT.

  Patient problems: Foreign Body In Patient; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629995 ↗
• InjuryFeb 2, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2019, WITH VIPER X-TAB CFS AND SFX. AFTER THE SURGERY, THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2024, DUE TO THE RODS FRACTURE. THE EVENT DATE IS UNKNOWN. THIS PATIENT HAS PARKINSON'S DISEASE, AND THE SURGEON BELIEVES THAT THE CAUSE OF THIS ROD FRACTURE IS NOT DUE TO THE PRODUCT OR THE SURGERY, BUT TO PARKINSON'S DISEASE. PATIENT STATUS/ OUTCOME: STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD-480MM THIS IS REPORT 2OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629019 ↗
• InjuryFeb 2, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2019, WITH VIPER X-TAB CFS AND SFX. AFTER THE SURGERY, THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2024, DUE TO THE RODS FRACTURE. THE EVENT DATE IS UNKNOWN. THIS PATIENT HAS PARKINSON'S DISEASE, AND THE SURGEON BELIEVES THAT THE CAUSE OF THIS ROD FRACTURE IS NOT DUE TO THE PRODUCT OR THE SURGERY, BUT TO PARKINSON'S DISEASE. PATIENT STATUS/ OUTCOME: STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD-480MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18628984 ↗
• InjuryDec 28, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION FOR A MULTIPLE VERTEBRAL FRACTURE ON (B)(6) 2019. AFTER THE SURGERY, THE ROD WAS BROKEN BETWEEN L4 AND L5. ADDITIONALLY, THE PLF-FUSION BONE WAS FRACTURED. A REVISION SURGERY WAS PERFORMED TO PREVENT PARALYSIS IN THE FUTURE. THE REVISION SURGERY WAS PERFORMED IN SEQUENCE AS FOLLOWS: THE EIGHT SCREWS INSERTED IN T10 TO L1 WERE REMOVED. THE SCREWS INSERTED IN L2 TO S2 WERE NOT REMOVED. FOUR TOP NOTCH CONNECTORS (PRODUCT CODE: 179771555) WERE USED TO FIX FOUR RODS (PRODUCT CODE: 179762480). TWO CROSS CONNECTORS WERE USED TO CONNECT THE TWO ADDITIONAL RODS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM ROD, STRAIGHT 480MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Vertebral Fracture

  MAUDE report 16062295 ↗
• InjuryDec 28, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION FOR A MULTIPLE VERTEBRAL FRACTURE ON (B)(6) 2019. AFTER THE SURGERY, THE ROD WAS BROKEN BETWEEN L4 AND L5. ADDITIONALLY, THE PLF-FUSION BONE WAS FRACTURED. A REVISION SURGERY WAS PERFORMED TO PREVENT PARALYSIS IN THE FUTURE. THE REVISION SURGERY WAS PERFORMED IN SEQUENCE AS FOLLOWS: 1. THE EIGHT SCREWS INSERTED IN T10 TO L1 WERE REMOVED. THE SCREWS INSERTED IN L2 TO S2 WERE NOT REMOVED. 2. FOUR TOP NOTCH CONNECTORS (PRODUCT CODE: 179771555) WERE USED TO FIX FOUR RODS (PRODUCT CODE: 179762480). 3. TWO CROSS CONNECTORS WERE USED TO CONNECT THE TWO ADDITIONAL RODS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM ROD, STRAIGHT 480MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Vertebral Fracture

  MAUDE report 16062294 ↗
• InjuryJun 14, 2022Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT A PRIMARY SPINAL FUSION PROCEDURE. ON (B)(6) 2022 THE PATIENT UNDERWENT A REMOVAL PROCEDURE BECAUSE THE FUSION IN THE LESION WAS OBTAINED. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE ROD (T10-L3) HAD BROKEN OFF. THE REMOVAL PROCEDURE WAS COMPLETED, AND ALL THE DEVICES WERE REMOVED. THE ROD¿S BREAKAGE DID NOT CAUSED ADVERSE EFFECT TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING/SET SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD-480MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 14688974 ↗
• InjuryApr 15, 2022Migration; Migration

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT UNDERWENT THE PRIMARY SPINAL FUSION PROCEDURE (L1-SAI) FOR TREATING PURULENT SPONDYLITIS. ON AN UNKNOWN DATE IT WAS FOUND THAT THE ROD HAD COME OFF THE SCREW (UNK). ON (B)(6) 2022 THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE FOR THE ROD REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD-480MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Purulent Discharge

  MAUDE report 14120684 ↗
• InjuryApr 12, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2020 THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE FOR TREATING THE 3RD LUMBAR SPINE FRACTURE. THE VIPER SYSTEM WAS APPLIED. NO ISSUE WAS REVEALED DURING MEDICAL FOLLOW-UPS. ON (B)(6) 2022 THE PATIENT UNDERWENT THE REMOVAL PROCEDURE. THE REASONS FOR THE REVISION PROCEDURE WAS BECAUSE THE VERTEBRAL FRACTURE (L3) SHOWED RECOVERY SINCE THE PRIMARY PROCEDURE. SO THEY CAME TO A CONCLUSION THAT SPINAL INSTRUMENTATION IS NO LONGER NEEDED FOR THE PATIENT, AND THE IMPLANTS SHOULD BE EXTRACTED. WHEN THE ROD IN QUESTION WAS REMOVED, IT WAS FOUND THAT THE ROD HAD BROKEN OFF. THE ROD IN QUESTION WAS LOCATED BENEATH A SCREW (L2 LEFT). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A VIPER ROD.

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

  MAUDE report 14084075 ↗
• InjuryAug 26, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, ON (B)(6) 2019 THE PRIMARY SPINAL FUSION WAS PERFORMED FOR TREATING L4 PSEUDO ARTICULATION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2021 IT WAS REPORTED THAT A REVISION PROCEDURE WOULD BE PERFORMED ON (B)(6) 2021 FOR REMOVING TWO BROKEN RODS. THE SURGEON COMMENTED AS FOLLOWS: IN HIS OPINION, AN ANTERIOR SUPPORT RECONSTRUCTION TECHNIQUE MIGHT HAVE NEEDED IN THE PRIMARY PROCEDURE. A SURGEON WHO PERFORMED THE PRIMARY PROCEDURE TOOK OTHER SURGICAL TECHNIQUE. THIS MIGHT HAVE TRIGGERED THE EVENT. THE PATIENT HAS SUFFERED FROM PARKINSON¿S DISEASE. BUT THE ITEM 1 COULD BE THE MAIN CAUSE FOR THE EVENT. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM ROD, STRAIGHT 480MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 12375379 ↗
• InjuryAug 26, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, ON (B)(6) 2019 THE PRIMARY SPINAL FUSION WAS PERFORMED FOR TREATING L4 PSEUDO ARTICULATION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2021 IT WAS REPORTED THAT A REVISION PROCEDURE WOULD BE PERFORMED ON (B)(6) 2021 FOR REMOVING TWO BROKEN RODS. THE SURGEON COMMENTED AS FOLLOWS: IN HIS OPINION, AN ANTERIOR SUPPORT RECONSTRUCTION TECHNIQUE MIGHT HAVE NEEDED IN THE PRIMARY PROCEDURE. A SURGEON WHO PERFORMED THE PRIMARY PROCEDURE TOOK OTHER SURGICAL TECHNIQUE. THIS MIGHT HAVE TRIGGERED THE EVENT. THE PATIENT HAS SUFFERED FROM PARKINSON¿S DISEASE. BUT THE ITEM 1 COULD BE THE MAIN CAUSE FOR THE EVENT. THIS REPORT IS FOR (1) VIPER 2 SYSTEM ROD, STRAIGHT 480MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 12375378 ↗
• InjuryFeb 22, 2021Break; Break

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CONSTRUCT BROKE WHEN THE PATIENT BENT OVER. THE LEFT ROD FRACTURED AT THE L5/S1 LEVEL. UPON FURTHER INVESTIGATION INTRA OPERATIVELY, IT WAS FOUND THAT THE 10MM CFX SCREW AT THE LEVEL OF S1 HAD BROKEN. BOTH THE BROKEN PIECE OF THE ROD FROM L5 TO S1 AND THE BROKEN S1 SCREW WERE REMOVED. THE S1 BROKEN 10MM SCREW THAT WAS REMOVED, WASN¿T REPLACED AS IT WAS THE MAXIMUM DIAMETER PEDICLE SCREW AVAILABLE ( NO BIGGER DIAMETER PEDICLE SCREW THAN 10MM). ANOTHER ROD WAS CONNECTED TO THE EXISTING ILIAC SCREW AND RECONNECTED TO THE PROXIMAL CONSTRUCT WITH A CONNECTOR. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM ROD, STRAIGHT 480MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 11357435 ↗
• InjuryNov 5, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A PROCEDURE IN THE LUMBAR SPINE TO TREAT TUBERCULOUS SPONDYLITIS. ON AN UNKNOWN POSTOPERATIVE DATE, IT WAS FOUND THAT TWO RODS HAD BROKEN OFF. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. COMPLICATIONS WITH THIS REVISION PROCEDURE WERE REPORTED UNDER (B)(4). THIS REPORT IS FOR A VIPER2 STRAIGHT ROD-480MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10792749 ↗
• InjuryNov 5, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A PROCEDURE IN THE LUMBAR SPINE TO TREAT TUBERCULOUS SPONDYLITIS. ON AN UNKNOWN POSTOPERATIVE DATE, IT WAS FOUND THAT TWO RODS HAD BROKEN OFF. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. COMPLICATIONS WITH THIS REVISION PROCEDURE WERE REPORTED UNDER (B)(4). THIS REPORT IS FOR A VIPER2 STRAIGHT ROD-480MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10792662 ↗
• InjurySep 25, 2020Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION ON (B)(6) 2020 DUE TO THE SPINAL ROD HAD MIGRATED SUPERIORLY. DURING THE REVISION THE UNITIZED SET SCREWS AND RODS WERE REPLACED. THE PATIENT HAD PREVIOUSLY IMPLANTED VERSE PEDICLE SCREWS, VERSE UNITIZED SET SCREWS, AND 5.5 MM TITANIUM RODS. ALL THE 4 SETS SCREWS ON THE LEFT HAND SIDE WERE LOOSE WHICH ALLOWED THE LEFT ROD TO MIGRATE AND DURING THE SURGERY THE 5 SET SCREWS ON THE RIGHT WERE IDENTIFIED TO BE LOOSE ALSO. THE RIGHT ROD DID NOT MOVE. THE SURGEON REPLACED ALL 9 SET SCREWS AND 2 RODS. THE SURGEON PERFORMED A REVISION BY REPLACING THE UNITIZED SET SCREWS AND RODS. CONCOMITANT DEVICES REPORTED: 5.5 EXP VERSE UNITIZED SET SCR (PART # 199721001, LOT # UNKNOWN, QUANTITY 9); 5.5 EXPEDIUM VERSE SCREWS (PART# 1997-21-645, LOT# UNKNOWN, QUANTITY UNKNOWN); 5.5 MM TITANIUM ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD-480MM. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10587753 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO THEATER FOR PAIN INVESTIGATION. DR (B)(6)TEMPORARILY REMOVED BOTH SFX A6 CONNECTORS AND ALL SET SCREWS. HE THEN REMOVED BOTH RODS AND DECOMPRESSED. THERE WAS NO SIGN OF IMPLANT FAILURE OR SCREW LOOSENING. THE CONSTRUCT WAS EXTENDED DOWN FROM S1 TO THE SACRAL 2 ALAR ILIAC BILATERALLY WITH VIPER SAI SCREWS.(8X90MM 179704890). TWO NEW COCR RODS WERE CUT FROM A SINGLE 480MM COCR ROD 196789480. ALL SET SCREWS WERE REPLACED AS WELL AS THE TWO SFX A6 CONNECTORS. THE SET SCREWS WERE THEN ALL TORQUED OF TWICE.

  Patient problems: No Code Available; Pain

  MAUDE report 8554650 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO THEATER FOR PAIN INVESTIGATION. DR (B)(6) TEMPORARILY REMOVED BOTH SFX A6 CONNECTORS AND ALL SET SCREWS. HE THEN REMOVED BOTH RODS AND DECOMPRESSED. THERE WAS NO SIGN OF IMPLANT FAILURE OR SCREW LOOSENING. THE CONSTRUCT WAS EXTENDED DOWN FROM S1 TO THE SACRAL 2 ALAR ILIAC BILATERALLY WITH VIPER SAI SCREWS.(8X90MM 179704890) TWO NEW COCR RODS WERE CUT FROM A SINGLE 480MM COCR ROD 196789480. ALL SET SCREWS WERE REPLACED AS WELL AS THE TWO SFX A6 CONNECTORS. THE SET SCREWS WERE THEN ALL TORQUED OF TWICE.

  Patient problems: No Code Available; Pain

  MAUDE report 8554610 ↗
• InjuryMar 1, 2019Break; Break

  IT WAS REPORTED PATIENT WAS REVISED DUE TO BROKEN ROD. DURING REVISION, SURGEON BROKE THREE DRIVERS WHILE INSERTING SCREWS.

  Patient problems: No Code Available

  MAUDE report 8383716 ↗
• InjuryFeb 27, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE FUSION SURGERY WAS PERFORMED ON (B)(6) 2019 TO FIX THE 8.9.10-L1.2.3. FIRST, THE SURGEON IMPLANTED ALL SCREWS AND CUT THE ROD TO PROPER LENGTH. THEN, WHEN THE SURGEON PERFORMED ROD BENDING, IT WAS REPORTED THAT THE SURGEON FELT THE BREAKING NOISE, AND RECOGNIZED PLATING ON ROD SURFACE WAS PEELING OFF. THE SURGEON CONFIRMED THAT THERE WAS NO PLATING FRAGMENT WAS REMAINED IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED BY REPLACING THE ROD TO NEW ROD (P/N AND LOT NUMBER WERE UNKNOWN). THERE WAS NO SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8375500 ↗

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