VIPER 179704880Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705034265728), received between Aug 15, 2018 and Sep 17, 2025 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A TIRF FOR AN ILIAC ON (B)(6) 2025, THE SI SET SCREW WAS STRIPPED, PREVENTING IT FROM TURNING AND PREVENTING THE APPLICATION OF TORQUE DURING FINAL TIGHTENING. THE 8.0 X 80MM SAI SCREW HAD STRIPPED THREADS ON THE SCREW HEAD, CAUSING THE SET SCREW TO BE STRIPPED. THE PROBLEM WAS RESOLVED BY SWAPPING THE SCREW AND THE SET SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074734 ↗
• InjuryAug 28, 2024Migration; Migration

  IT WAS REPORTED THROUGH LEGAL DOCUMENTATION, THE PATIENT SUSTAINED INJURIES DUE TO A CAR ACCIDENT ON FEBRUARY 2020. SUBSEQUENTLY, ON (B)(6) 2020, PLAINTIFF THE UNDERWENT AN OCCIPUT-C3 POSTERIOR SPINAL FUSION WHERE BONE SCREWS AND TITANIUM RODS WERE PLACED IN HER CERVICAL SPINE. PATIENT HAD GOOD RECOVERY. ON APRIL 30, 2020, PATIENT WAS SEEN AND X-RAYS LEFT THE IMPRESSION OF AN ¿INSTRUMENTED POSTERIOR SPINAL FUSION AND POSTERIOR DECOMPRESSION FROM THE OCCIPUT THROUGH C3 FOR MANAGEMENT OF CERVICAL SPINE FRACTURES.¿ ALSO, X-RAYS OF HER RIGHT SHOULDER SHOWED A CLAVICULAR FRACTURE AND THORACIC COMPRESSION FRACTURES AT THE T5 AND T6 LEVELS. PLAINTIFF WAS DIAGNOSED WITH A ¿CLOSED STABLE BURST FRACTURE OF FIRST CERVICAL VERTEBRAE WITH ROUTINE HEALING.¿ ON (B)(6) 2020 PATIENT WAS SEEN AND WAS NOTED DOING PHYSICAL THERAPY AND WAS IMPROVING. ON MAY 6, 2020 CT SCANS OF THE CERVICAL AND THORACIC SPINE SHOWED: OCCIPUT-C3 POSTERIOR BONE FUSION WITHOUT EVIDENCE FOR HARDWARE FAILURE¿ AND FRACTURES AT THE T3-T6 LEVELS. ON MAY 11, 2020, PATIENT WAS TREATED FOR PAIN MANAGEMENT AND WAS DIAGNOSED WITH CERVICALGIA AND PAIN IN THE THORACIC SPINE. ON JUNE 2, 2020 PATIENT WAS SEEN AND X-RAYS OF THE CERVICAL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intervertebral Disc Compression or Protrusion

  MAUDE report 20087433 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON PERFORMED A SPINE SURGERY (T10-S2), AND IT WENT AS PLANNED. AT SOME POINT WELL AFTER THE CASE, TWO SAI SCREWS BROKE. THE PATIENT IS AWARE AND HAS DISCUSSED WITH THE SURGEON, AND THERE IS NO PLANNED REVISION SURGERY AT THIS TIME. THIS REPORT INVOLVES ONE VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17862153 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON PERFORMED A SPINE SURGERY (T10-S2), AND IT WENT AS PLANNED. AT SOME POINT WELL AFTER THE CASE, TWO SAI SCREWS BROKE. THE PATIENT IS AWARE AND HAS DISCUSSED WITH THE SURGEON, AND THERE IS NO PLANNED REVISION SURGERY AT THIS TIME. THIS REPORT INVOLVES ONE VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17861324 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON PERFORMED A SPINE SURGERY (T10-S2), AND IT WENT AS PLANNED. AT SOME POINT WELL AFTER THE CASE, TWO SAI SCREWS BROKE. THE PATIENT IS AWARE AND HAS DISCUSSED WITH THE SURGEON, AND THERE IS NO PLANNED REVISION SURGERY AT THIS TIME. THIS REPORT INVOLVES ONE VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17861316 ↗
• InjuryFeb 16, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT THE PRIMARY POSTERIOR SPINAL FUSION(PSF) PROCEDURE (TH9~SAI) FOR TREATING ASD. ON (B)(6) 2022, THE ROD AT SAI LEFT WAS BACKED OUT AND THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE ON THE SAME DAY. THIS EVENT INVOLVES PREVIOUSLY REPORTED UNDER (B)(4). THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 13544954 ↗
• InjuryJan 14, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT THE PRIMARY PSF PROCEDURE IN THE ILIUM FOR TREATING ASD. ON AN UNKNOWN POSTOPERATIVE DATE AFTER DISCHARGE FROM THE HOSPITAL, THE PATIENT FELT BACK PAIN. IT WAS FOUND THAT THE SAI SCREW HAD BROKEN OFF IN THE PELVIS. ON (B)(6) THE PATIENT WAS SCHEDULED TO UNDERGO A REVISION PROCEDURE (REMOVE A ROD; REPLACE THE SCREW IN QUESTION; REFUSION). NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER TI SAI POLY 8X80MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 13261272 ↗
• InjuryDec 14, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE VIPER SYSTEM WIDE LAG SCREW IMPLANTED IN THE PATIENT BROKE AT THE TRANSITION BETWEEN THE SMOOTH AND THREADED PORTION OF THE SCREW. THE ORIGINAL SURGERY TOOK PLACE IN 2018. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. UPON REMOVAL, ONLY THE SMOOTH PART OF THE SCREW SHANK COULD BE RETRIEVED AND THE PROXIMAL THREADED TIP OF THE SCREW WAS LEFT IN THE ILIUM. AN ILIAC BOLT WAS USED TO REVISE THE CONSTRUCT. THIS REPORT IS FOR ONE (1) VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13003716 ↗
• InjurySep 17, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PRIMARY POSTERIOR FUSION WAS PERFORMED. ON (B)(6) 2021 IT WAS FOUND THAT THE ROD HAD BROKEN OFF AND THE SCREW HAD LOOSENED. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2021. THE BROKEN TITANIUM ROD WAS REPLACED WITH A COBALT ROD. CONCOMITANT DEVICES: UNKNOWN LOCKING/SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). CONN O/O SD TOP NTCH 5.5X5.5 T (PART# 179771555, LOT# UNKNOWN, QTY TWO). THIS REPORT IS FOR A VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

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

  MAUDE report 12490529 ↗
• InjurySep 17, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PRIMARY POSTERIOR FUSION WAS PERFORMED. ON (B)(6) 2021 IT WAS FOUND THAT THE ROD HAD BROKEN OFF AND THE SCREW HAD LOOSENED. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2021. THE BROKEN TITANIUM ROD WAS REPLACED WITH A COBALT ROD. CONCOMITANT DEVICES: UNKNOWN LOCKING/SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). CONN O/O SD TOP NTCH 5.5X5.5 T (PART# 179771555, LOT# UNKNOWN, QTY TWO). THIS REPORT IS FOR A VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

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

  MAUDE report 12490460 ↗
• InjuryDec 9, 2019Unintended Movement; Unintended Movement

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT RETURNED TO THEATRE FOR REVISION OF LEFT SIDED ROD PULL OUT FROM A VIPER SAI 8X80MM SCREW. PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION AND ROD DISENGAGED FROM SAI SCREW. PT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING AND REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. DEVICE WAS EXPLANTED DUE TO ROD PULL OUT SAI SCREW. PATIENT STATUS/ OUTCOME / CONSEQUENCES IS UNKNOWN. DEVICE WAS DISPOSED OF. THIS REPORT IS FOR ONE (1) VIPER TI SAI POLY 8X80MM. THIS REPORT IS 4 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9437187 ↗
• InjuryDec 6, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THIS REPORT IS 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9433145 ↗
• InjuryFeb 5, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE POSTERIOR LUMBAR FUSION SURGERY WAS PERFORMED TO FIX TH9-S2 ON (B)(6) 2019. AFTER THE ALL SCREWS WERE IMPLANTED (REPORTED SCREW (P/N:179704880) WAS USED FOR S2), WHEN THE SURGEON INSERTED THE ROD FROM S2, IT WAS REPORTED THAT THE SET SCREW COULD NOT BE FINAL TIGHTENING SO THAT THE SURGEON COULD NOT INSERTED TO THE SCREW. THEN, THE SURGEON REPLACED THE SET SCREW AND ATTEMPTED FOR FINAL TIGHTENING, BUT REPLACED SET SCREW COULD NOT BE TIGHTENED, NEITHER. FINALLY, THE SURGEON REVISED THE SCREW TO 8.0MM X 70MM AND COMPLETED TO TIGHTEN THE SET SCREW. AFTER THE SURGERY, OUR SALES REP CHECKED THE CONDITION OF REPORTED SCREW, AND FOUND THAT THE THREAD OF THE SCREW HEAD WAS BROKEN. THERE WAS LESS THAN 30 MIN SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8307098 ↗
• InjuryNov 5, 2018Break; Break

  IT WAS REPORTED THAT THE SCREW HEAD OF THE SAI WAS BROKEN DURING POSTERIOR LUMBAR FUSION SURGERY ON (B)(6) 2018. FIRST, THE SURGEON FELT DIFFICULTY TO INSERT THE SCREW INTO THE PATIENT¿S BODY, SO THAT THE SURGEON USED VBD REDUCTION INSTRUMENT TO INSERT THE SCREW. HOWEVER, THE AT THE FINAL FIXATION OF THE SCREWS, THE REPORTED SCREW WAS NOT PROPERLY INSERTED. THEN, THE SURGEON RECOGNIZED THAT THE SCREW HEAD WAS BROKEN. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE SCREW (P/N AND LOT NUMBER WERE UNKNOWN). THE SURGEON CONFIRMED THAT THERE WERE NO BROKEN PARTS IN THE PATIENT¿S BODY, DURING AND AFTER THE SURGERY UNDER X-RAY. THERE WAS LESS THAN 30MIN. SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039227 ↗
• InjurySep 11, 2018Break; Break

  IT WAS REPORTED THAT THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2015 BY USING EXPEDIUM PLUS SPINE SYSTEM FOR SACROILIAC JOINT. ON (B)(6) 2018, THE PATIENT COMPLAINED THE PAIN AT SACROILIAC JOINT, SO THAT THE SURGEON FOUND THAT THE REPORTED SCREW WAS BROKEN UNDER X-RAY (IT WAS UNKNOWN WHEN THE BREAKAGE WAS OCCURRED). IT WAS REPORTED THAT THE ONLY BROKEN SCREW WAS EXPLANTED ON (B)(6) 2018 FROM THE PATIENT¿S SACROILIAC JOINT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7864024 ↗
• InjuryAug 15, 2018Break; Break

  ON (B)(6) 2017, THE TLIF SURGERY FOR ADULT SPINAL DEFORMITY (ASD) WAS PERFORMED BY USING THE EXPEDIUM PUS SYSTEM (SACRAL-ALAR-ILIAC FIXATION). THE FIXED SITE WAS S2 AI. ON (B)(6) 2018, IT WAS REPORTED THAT THE SCREW (179704880, PART#: UNK) HAD BEEN BROKEN IN THE SACROILIAC JOINT, WHICH WAS NOTICED LATER THROUGH THE X-RAY PHOTOS TAKEN AROUND THREE MONTHS AFTER THE TLIF SURGERY. THE (B)(6) MALE PATIENT HAS A PAIN ON THE OPPOSITE SIDE OF THE SITE WHERE THE SCREW IN QUESTION WAS BROKEN. NO CAUSAL RELATION WAS REPORTED BETWEEN THE BROKEN SCREW AND THE SITE WHERE HE FEELS A PAIN. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL.

  Patient problems: Pain; Spinal Column Injury

  MAUDE report 7784113 ↗