VIPER 186731845Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705034352190), received between Aug 28, 2017 and Jan 16, 2024 — classified as 6 injuries, 8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HEAD OF SCREW POPPED OFF WHILE TIGHTENING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 8X45MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519935 ↗
• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE 35 MM ROD IS IN A SCREW HEAD (8X45) WITH A SET CAP OVER IT. FINAL TIGHTENER STRIPPED AND HEAD OF SCREW ENDED UP GETTING RIPPED OUT FROM SHAFT OF SCREW. PATIENT WAS NOT HARMED AT ALL. REPLACED ROD AND SCREW. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. NO PATIENT CONSEQUENCE WAS THERE. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 8X45MM THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18506905 ↗
• MalfunctionJul 1, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHILE THE SCREW WAS BEING ATTACHED TO THE SCREWDRIVER IN THE LESION, THE TIP OF THE SCREWDRIVER BROKE OFF. NO FRAGMENT WAS LEFT IN THE LESION. THE SCREW WAS REMOVED FROM THE LESION, TOO. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT CORTEX SCREW WAS WORN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14885811 ↗
• MalfunctionApr 11, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: ON AN UNKNOWN DATE THE PATIENT UNDERWENT A UNKNOWN PRIMARY PROCEDURE. ON (B)(6) 2022, A SPINE REMOVAL PROCEDURE WAS PERFORMED. THE SCREWHEAD CAME OFF DURING THE PROCEDURE. A FRAGMENT WAS REMOVED FROM THE LESION. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 8 X 45MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073396 ↗
• InjuryAug 13, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR REVISION PROCEDURE (L3-S) DUE TO SUFFERED FROM ASD AT L3. WHEN THE REVISION PROCEDURE (L3-S) WAS PERFORMED, SCREW LOOSENING WAS REVEALED, WHICH WAS REPLACED WITH A NEW SCREW. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THE PRIMARY OLIF AND TLIF (L3-SAI) WERE PERFORMED ON (B)(6) 2019. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1)5.5 TI CORT FIX 8X45MM. THIS REPORT IS 3 OF 7 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12319617 ↗
• MalfunctionSep 14, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE SURGEON PREPARED THE PATIENT'S L4 PEDICLE ON THE LEFT SIDE FOR PEDICLE SCREW PLACEMENT. THE SURGEON TAPPED THE PREPARED PATHWAY WITH THE 7.0MM TAP AND DETERMINED THE APPROPRIATE SCREW SIZE. HE REQUESTED THE 8.0X45MM SCREW, WHICH THE SURGICAL TECH LOADED ON THE CORRESPONDING NAVIGATION DRIVER. HE ADVANCED THE PEDICLE SCREW DOWN THE PEDICLE AND APPROXIMATELY HALFWAY DOWN, THE DRIVER TIP BROKE OFF IN THE RECESS OF THE PEDICLE SCREW. THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN TIP, SO HE PROCEEDED TO REMOVE THE POLYAXIAL HEAD FROM THE SCREW AND REMOVE THE PEDICLE SCREW WITH THE BROKEN SCREW REMOVAL INSTRUMENT. THE BROKEN DRIVER WAS REMOVED FROM THE STERILE FIELD AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. FRAGMENTS WERE GENERATED AND EASILY REMOVED. PATIENT STATUS IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: SCREW REMOVER, BROKEN (PART# RS2013150, LOT# 830029B16, QUANTITY 1). 5.5 VIPER UNIV POLY DRIVER (PART# 279734000N, LOT# GM5358811, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 8X45MM. THIS IS REPORT 2 OF 2

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529013 ↗
• InjuryNov 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT A POSTERIOR LUMBAR SPINAL FUSION (L2-SAI) TREATING DEGENERATIVE DISEASE ON (B)(6) 2019. THE SURGEON TRIED TO REMOVE A FORMERLY IMPLANTED CFS7.0-45MM SCREW ON L3 LEFT AND IMPLANT A CFS8.0-45MM SCREW INSTEAD. BECAUSE THE NEW SCREW SEEMED TIGHT (STICKING OUT APPROXIMATELY 2MM THAN EXPECTED), THE SURGEON TRIED TO REMOVE IT. THEN, THE FOLLOWING EVENTS OCCURRED IN SEQUENCE: THE TIP OF THE DRIVER SHAFT BROKE. AS THE SURGEON TRIED TO REMOVE THE SCREW BY FIXING A ROD AND A SETSCREW, THE SCREW HEAD OF THE CORTICAL FIX SCREW CAME OFF. THE ROD HOLDER BROKE. THE SURGEON DECIDED TO LEAVE THE FRAGMENTED CORE OF THE CORTICAL FIX SCREW IN THE PATIENT¿S BODY DUE TO THE LIMITED SURGICAL TIME. SINCE L3 LEFT WAS NOT FIXED, THE SCREW STABILIZATION HAS DECREASED A LITTLE. THE PATIENT IS RECOVERING. CONCOMITANT DEVICES: SETSCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), ROD (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 5.5 TITANIUM (TI) CORTEX FIX SCREW 8X45MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9355442 ↗
• InjuryFeb 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLIF SURGERY WAS PERFORMED ON UNKNOWN DATE (ABOUT A YEAR AGO) TO FIX L4 WITH 7MM SCREW (P/N AND LOT NUMBER WERE UNKNOWN). AFTER ABOUT A YEAR FROM PRIMARY SURGERY, THE PATIENT¿S GOT ADJACENT SEGMENTAL DISEASES. THUS, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 TO REPLACE 7MM SCREW TO 8MM SCREW. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 8325265 ↗
• MalfunctionJan 24, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT ON DECEMBER 18TH, DR. (B)(6) WAS PERFORMING A REVISION OF A PRIOR FUSION WITH BILATERAL PEDICLE SCREWS FROM L3-S1. WHILE USING THE T25 ATTACHMENT (ITEM: HD203T25) FROM THE SRB SET, HE TRIED TO LOOSEN ONE SET SCREW WHEN THE TIP OF THIS SHEERED OFF. THE PIECE WAS RETRIEVED AND ALL SCREWS WERE REMOVED SUCCESSFULLY. WHILE INSERTING A NEW 8X45MM SCREW (ITEM: 1867-31-845) INTO THE LEFT L3 PEDICLE, THE EXPEDIUM SCREW DRIVER (#2797-12-400) TIP BROKE OFF INSIDE THE SCREW. THE SCREW WAS REMOVED AND A NEW SCREW WAS SUCCESSFULLY PLACED. LATER IN THE CASE WHILE TRYING TO INSERT A NEW SCREW (#1867-31-750), THE SAME THING HAPPENED WHERE THE TIP OF THE EXPEDIUM DRIVER BROKE. AGAIN, AFTER THE SCREW HEAD/SCREW WAS REMOVED , A NEW REPLACEMENT WAS SUCCESSFULLY IMPLANTED. LATER IN THE CASE WHEN THE SURGEON WAS TRYING TO PLACE A 10X65MM SCREW (#1797-12-165), THE TIP OF ANOTHER SCREW DRIVER (ITEM #2797-34-000) BROKE AS WELL. THE SCREW WAS PROPERLY PLACED SO NO ADJUSTMENT TO THE SCREW NEEDED TO ME MADE. I ASKED THE SURGEON IF THE BROKE TIP HAD STAYED IN THE SCREW ITSELF, AT WHICH POINT HE SAID HE BELIEVED IT DID. I STRONGLY RECOMMENDED THAT HE RETRIEVE THE BROKEN PIECE. I BELIEVE HE R

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8274395 ↗
• InjuryOct 10, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE POSTERIOR SPINE FUSION SURGERY WAS PERFORMED ON (B)(6) 2018 TO FIX L3/4/5 DUE TO DEGENERATIVE LUMBAR SCOLIOSIS. "THE" AFTER THE SURGERY IT WAS REPORTED THAT THE BLEEDING COULD NOT STOP, SO THAT THE SURGEON REVISED THE SCREW IN QUESTION ON (B)(6) 2018. ON (B)(6) 2018, THE SURGEON FOUND THE PEDICLE FRACTURE. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Injury; Not Applicable

  MAUDE report 7952691 ↗
• MalfunctionJun 14, 2018Break; Break

  IT WAS REPORTED THAT THE DR. WHILE INSERTING THE SCREW, THE SCREW BROKE. HE WAS UNABLE TO GET THE SCREW OUT AND HAD TO LEAVE IN THE BROKEN PART.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7602572 ↗
• InjuryOct 17, 2017Break; Break

  A FEW YEARS AGO, PLIF SURGERY WAS PERFORMED USING CANNULATED CORTICAL FIX SCREW 7 X 45MM (PART#: 186731745, LOT#: UNK). THE FIXED AREA WAS L5 - S. ON (B)(6) 2017, REVISION SURGERY WAS PERFORMED DUE TO LUMBAR DISC HERNIA (L3 - L5) AND PSEUDARTHROSIS (L5 - S). FOR DETAILS OF THIS REVISION, PLEASE REFER TO (B)(4). DURING THE REVISION SURGERY, THE FOLLOWING ISSUES HAPPENED WHILE THE SURGEON WAS INSERTING TWO CFS SCREWS (PART#: 186731845, LOT#: AVKDYF) TO S1. THE TIP OF THE DRIVER (PART#: 286725020, LOT#: AG2098256) GOT BROKEN AND WAS LEFT IN THIS CFS SCREW, HOWEVER, THE SURGEON SUCCESSFULLY REMOVED THE SCREW AND THE TIP TOGETHER BY USING SI POLYAXIAL DRIVER (S1, RIGHT SIDE). SIMILARLY, THE TIP OF THE DRIVER (PART#: 279734000, LOT#: MI34169) GOT BROKEN AND WAS LEFT IN THIS CFS SCREW. THE SURGEON TRIED TO REMOVE THE BROKEN TIP, HOWEVER, HE COULD NOT REMOVE IT. THEN, THE SCREW HEAD WAS REMOVED FROM THIS CFS SCREW. THE BROKEN TIP AND SCREW SHAFT WERE LEFT IN THE PATIENT¿S BONE (S1 LEFT SIDE). THE SURGERY WAS COMPLETED WITH A 60-MINUTE EXTENSION. NO FURTHER INFORMATION HAS BEEN PROVIDED FROM THE HOSPITAL.

  Patient problems: Injury

  MAUDE report 6954495 ↗
• InjuryOct 17, 2017Break; Break

  A FEW YEARS AGO, PLIF SURGERY WAS PERFORMED USING CANNULATED CORTICAL FIX SCREW 7 X 45MM (PART#: 186731745, LOT#: UNK). THE FIXED AREA WAS L5 - S. ON (B)(6) 2017, REVISION SURGERY WAS PERFORMED DUE TO LUMBAR DISC HERNIA (L3 - L5) AND PSEUDARTHROSIS (L5 - S). FOR DETAILS OF THIS REVISION, PLEASE REFER TO (B)(4). DURING THE REVISION SURGERY, THE FOLLOWING ISSUES HAPPENED WHILE THE SURGEON WAS INSERTING TWO CFS SCREWS (PART#: 186731845, LOT#: AVKDYF) TO S1. THE TIP OF THE DRIVER (PART#: 286725020, LOT#: AG2098256) GOT BROKEN AND WAS LEFT IN THIS CFS SCREW, HOWEVER, THE SURGEON SUCCESSFULLY REMOVED THE SCREW AND THE TIP TOGETHER BY USING SI POLYAXIAL DRIVER (S1, RIGHT SIDE). SIMILARLY, THE TIP OF THE DRIVER (PART#: 279734000, LOT#: MI34169) GOT BROKEN AND WAS LEFT IN THIS CFS SCREW. THE SURGEON TRIED TO REMOVE THE BROKEN TIP, HOWEVER, HE COULD NOT REMOVE IT. THEN, THE SCREW HEAD WAS REMOVED FROM THIS CFS SCREW. THE BROKEN TIP AND SCREW SHAFT WERE LEFT IN THE PATIENT¿S BONE (S1 LEFT SIDE). THE SURGERY WAS COMPLETED WITH A 60-MINUTE EXTENSION. NO FURTHER INFORMATION HAS BEEN PROVIDED FROM THE HOSPITAL.

  Patient problems: Injury

  MAUDE report 6954433 ↗
• MalfunctionAug 28, 2017Break; Break

  IMPLANT BROKE DURING INSERTION. COMPLAINT FORM SENT TO REP PER COMPLAINT FORM: WHEN PLACING THE REVISION SCREW, THE SCREWDRIVER MADE A POPPING NOISE WHICH WAS THE TIP OF THE DRIVER BREAKING. THE TIP WAS STUCK IN THE SCREW AND WE HAD TO ATTACH A ROD TO REMOVE. WE BROKE OFF THE HEAD OF THE SCREW ATTEMPTING TO REMOVE AND THEN USED A REVERSE THREADED REMOVAL TIP IN ORDER TO REMOVE THE SCREW SHAFT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6824164 ↗