VIPER 286715500Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034214078), received between Jun 23, 2017 and Jun 17, 2024 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, IT WAS CONFIRMED THAT THERE WAS RESIDUAL BLOOD IN THE HOLLOW PORTION OF THE PRODUCTS IN QUESTION. THEY WERE CLEANED AND STERILIZED AGAIN AT THE HOSPITAL FOR USE ON THE FOLLOWING DAY, WEDNESDAY, (B)(6) 2024. THE FACILITY HAS A VERY HIGH LEVEL OF INFECTION AWARENESS. IT IS LIKELY TO AFFECT PRODUCT ADOPTION. THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM TAP, CANNULATED AND SELF-DRILLING 5MM 30-60MM PLUS OR MINUS 0.24 PERCENT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19546633 ↗
• MalfunctionJun 14, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 THE DEVICE WAS BROKEN INTO TWO PIECES DURING THE SURGERY. ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) VIPER2 5MM SELF DRILLING TAP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542239 ↗
• MalfunctionMar 12, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2024, TAP BROKE OFF IN SITU AND GOT STUCK IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME WAS GOOD. THERE WAS A SURGICAL DELAY BUT IT IS UNKNOWN HOW LONG IT WAS. THIS REPORT IS FOR ONE (1) VIPER2 5MM SELF DRILLING TAP, THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 18886981 ↗
• MalfunctionMar 7, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING A PLIF FOR THE LUMBAR STENOSIS BEFORE STERILIZATION, STEIN WAS FOUND IN THE HOLLOW PART OF THE DEVICES. THE DEVICES WERE DELIVERED ON THE OPERATION DAY, AND THE SURGEON DETERMINED THAT IT WOULD TAKE TIME TO CLEAN. THEREFORE, OTHER SAME DEVICES WERE USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM TAP, CANNULATED AND SELF-DRILLING 5MM 30-60MM PLUS OR MINUS 0.24 PERCENT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496515 ↗
• MalfunctionOct 27, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN RUSSIA AS FOLLOWS: IT WAS REPORTED THAT ON OCTOBER 4, 2022, A TAP FROM THE VIPER 2 SET BROKE DURING THE OPERATION. A DELAY IN THE SURGERY OCCURRED DUE TO THE FACT THAT THE BROKEN PART OF THE TAP HAD TO BE REMOVED FROM THE VERTEBRA. THE DELAY WAS APPROXIMATELY 20 MINUTES. THE OPERATION WAS COMPLETED SUCCESSFULLY. THE TAP WAS REMOVED, THE SCREW WAS INSTALLED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM TAP, CANNULATED AND SELF-DRILLING 5MM 30-60MM PLUS OR MINUS 0.24 PERCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680393 ↗
• InjurySep 15, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN RUSSIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE OPERATION WAS PERFORMED TO INSTALL THE CAGE AND VIPER 2 SCREWS. FOUR VIPER 2 SCREWS WERE INSTALLED. THE FIRST SCREW WAS INSTALLED USING A SIZE 5 TAP. WHILE INSTALLING THE SECOND SCREW, THE TAP BROKE IN THE PEDICLE OF THE VERTEBRA, AND THE REMOVAL OF THE FRAGMENTS FAILED. THE SCREW WAS INSTALLED TO THIS VERTEBRA AFTERWARD, BUT ALONG A DIFFERENT TRAJECTORY. THE REMAINING TWO SCREWS WERE INSTALLED USING A SIZE 4 TAP. THE PATIENT'S STATUS WAS REPORTED AS SATISFACTORY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM TAP, CANNULATED AND SELF-DRILLING 5MM 30-60MM PLUS OR MINUS 0.24 PERCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15427990 ↗
• InjuryMar 11, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN TAIWAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, SURGEON USED AN SURGICAL INSTRUMENT (SCREW TAP) TO FORM A THREAD ON THE PATIENT'S BONE, THE PATIENT'S BONE WAS TOO HARD. THE FRONT END OF TAP WAS BROKEN INTO THE PATIENT'S L5 VERTEBRAL BODY. THE SURGEON COULD NOT REMOVE IT AFTER REPEATED ATTEMPTS AND IT REMAINED IN PATIENT'S BODY. THIS REPORT IS FOR ONE (1) VIPER2 5MM SELF DRILLING TAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13736226 ↗
• InjuryFeb 25, 2021Break; Entrapment of Device; Break; Entrapment of Device

  THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11380674 ↗
• MalfunctionJun 17, 2019Break; Break

  THE FOLLOWING WAS REPORTED: UNKNOWN DEFECT OF INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8705005 ↗
• MalfunctionMay 8, 2019Break; Break

  IT WAS REPORTED THAT THE PRODUCT BROKE DURING PROCEDURE. TO REMOVE THE BROKEN PART PHYSICIAN SPEND 2 ADDITIONAL HOURS. NO ADDITIONAL DETAIL AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8591946 ↗
• MalfunctionJan 14, 2019Break; Break

  IT WAS REPORTED THE SURGEON WAS TAPPING OVER A WIRE INTO VERY SCLEROTIC BONE ON THE CONCAVE SIDE OF A SCOLIOTIC CURVE. THE TAP BEGAN "SQUEAK" AND BECAME HARD TO TURN. SUDDENLY IT BEGAN TO SPIN FREELY AS WE NOTICED THAT IT HAD BROKEN IN THE BONE. THE SURGEON THEN "RETRIEVE" THE WIRE FROM THE BONE AND DETERMINED THAT IT WOULD BE MORE DETRIMENTAL TO RETRIEVE THE BROKEN COMPONENT THAN IT WOULD BE TO SIMPLY LEAVE IT IN. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. ACTION TAKEN WHEN EVENT OCCURRED? NONE - DETERMINED TO BE MORE INVASIVE TO RETRIEVE PIECE. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES? UNKNOWN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 8244937 ↗
• MalfunctionJun 23, 2017Break; Break

  THERE ARE 100+ ITEMS PLACED ON DC ORTHOKIT QUARANTINE DUE TO BREAKAGES, FUNCTIONAL TESTS FAILURES. THIRTY EIGHT PERTAIN TO DEPUY SPINE PRODUCTS. IN ALL CASES NO DATA AVAILABLE IF ANY INJURES OR ADVERSE EVENTS. NO INFORMATION ABOUT SURGERY, DELAYS, PATIENT RELATED DATA. ONLY PRODUCT CODE/LOT DESCRIPTION AND BREAKAGE DEFINITION IS AVAILABLE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6663995 ↗