VIPER 286740020Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10705034214757), received between Oct 29, 2020 and Dec 10, 2025 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (19 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025. DURING THE SURGERY, THE COMPRESSOR COULD NOT BE USED AS IT DID NOT MOVE IN EITHER THE DISTRACTION OR COMPRESSION DIRECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AFTER USING THE OTHER INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770573 ↗
• MalfunctionDec 4, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. DURING THE SURGERY, UNKNOWN DEFECT OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY NO DELAY. WE ARE CONFIRMING ABOUT DETAILS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717856 ↗
• MalfunctionJul 23, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT UPON RETURN OF THE PRODUCT, IT WAS DISCOVERED THAT THE RAIL MOVEMENT OF THE PRODUCT IN QUESTION WAS NOT SMOOTH. BECAUSE THE PRODUCT IN QUESTION HAD NOT BEEN USED IN SURGERY, IT WAS THOUGHT POSSIBLE THAT ITS MOVEMENT WAS NOT SMOOTH FROM THE START. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 22580138 ↗
• MalfunctionMay 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. THE SURGEON WANTED TO DISTRACT ON THE PEDICLE SCREWS; ON ATTACHING THE DISTRACTION RACK, ONE OF THE TUBE ALIGNERS WOULDN'T ATTACH PROPERLY. ANOTHER ONE OFF THE SAME TRAY WAS USED INSTEAD. THE BROKEN ONE WAS REVIEWED AT THE END OF THE CASE AND FOUND TO BE FAULTY. PROCEDURE WAS COMPLETED WITH MINIMAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994043 ↗
• MalfunctionJan 8, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE GEAR TO COMPRESS/DISTRACT IS STUCK. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21102002 ↗
• MalfunctionOct 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE ISSUE WAS NOTED PREOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996273 ↗
• MalfunctionAug 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DISTRACTORS' TUBES THAT GOES OVER THE TOWERS WILL NOT CONTRACT WHEN TIGHTENED SO THAT THE SPROCKET LOCKS THE POSITION OF THE TOWERS. THIS CREATES DIFFICULTIES TO THEN COMPRESS AND DISTRACT, AS THE TOWERS POSITION IS NOT LOCKED OR HOLDS ITS POSITION. WHEN TIGHTENING, ONLY THE SCREWS TIGHTEN, WHILE THE TUBES OF THE TOWERS DO NOT PULL AGAINST THE INSTRUMENT SO THAT THE GEARS MEET EACH OTHER AND LOCK THE TOWER'S POSITION. THIS APPLY FOR BOTH OF THE INSTRUMENTS, AND FOR ALL 4 TUBES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) VIPER3D COMPRESSOR/DISTRACTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662258 ↗
• MalfunctionAug 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON AUGUST 17, 2023, THE DISTRACTORS' TUBES THAT GOES OVER THE TOWERS WILL NOT CONTRACT WHEN TIGHTENED SO THAT THE SPROCKET LOCKS THE POSITION OF THE TOWERS. THIS CREATES DIFFICULTIES TO THEN COMPRESS AND DISTRACT, AS THE TOWERS POSITION IS NOT LOCKED OR HOLDS ITS POSITION. WHEN TIGHTENING, ONLY THE SCREWS TIGHTEN, WHILE THE TUBES OF THE TOWERS DO NOT PULL AGAINST THE INSTRUMENT SO THAT THE GEARS MEET EACH OTHER AND LOCK THE TOWER'S POSITION. THIS APPLY FOR BOTH OF THE INSTRUMENTS, AND FOR ALL 4 TUBES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) VIPER3D COMPRESSOR/DISTRACTOR. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662250 ↗
• MalfunctionJun 14, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE IS BROKEN. NO OTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) VIPER3D COMPRESSOR/DISTRACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17123438 ↗
• MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE SURGEON COULD NOT TIGHTEN THE MECHANISM ON THE DEVICE APPROPRIATELY. TWO OUT OF THE THREE PARTS OF THE MECHANISM WERE NOT FULLY FUNCTIONAL. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THERE WAS A DELAY OF 5 MINUTES DUE TO THE EVENT. THERE WAS NO PATIENT IMPACT. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM COMPRESSION/DISTRACTION RACK 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059883 ↗
• MalfunctionMar 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING A SPINAL FUSION (T9) FOR THE SPINAL TRAUMA THE SCREW PART OF THE DISTRACTER THAT OPERATES TO FIX THE ANGLE OF THE EXTENSION SLEEVE BECAME STUCK AFTER BEING TIGHTENED AND LOOSENED SEVERAL TIMES WITH THE HANDLE FOR ADJUSTMENT OF THE CORRECTION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. WHEN THE SALES REP CHECKED THE DEVICE AFTER THE SURGERY, ONE SCREW PART COULD NOT BE TURNED WITH A SCREWDRIVER. THE ANGLE OF THE EXTENSION SLEEVE COULD NOT BE FIXED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER3D COMPRESSOR/DISTRACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522248 ↗
• MalfunctionJan 6, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, TWO (2) VIPER COMPRESSOR/DISTRACTOR RACKS WERE LOOSE WHEN IT WAS POSITIONED EITHER FOR COMPRESSION OF DISTRACTION. SURGERY WAS DELAYED BY 5 MINUTES DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM COMPRESSION/DISTRACTION RACK 5.5. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118529 ↗
• MalfunctionJan 4, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE VIPER COMPRESSOR/DISTRACTOR RACK WAS LOOSE WHEN IT WAS POSITIONED EITHER FOR COMPRESSION OF DISTRACTION. SURGERY WAS DELAYED BY 5 MINUTES DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM COMPRESSION/DISTRACTION RACK 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095146 ↗
• MalfunctionJul 29, 2022Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON RECEIPT OF THE LOAN SET AT THE LOCAL WAREHOUSE, IT WAS VERIFIED THAT THE GEARS WOULD NOT COMPRESS OR DISTRACT AS INTENDED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM COMPRESSION/DISTRACTION RACK 5.5. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15133673 ↗
• MalfunctionJul 29, 2022Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON RECEIPT OF THE LOAN SET AT THE LOCAL WAREHOUSE, IT WAS VERIFIED THAT THE GEARS WOULD NOT COMPRESS OR DISTRACT AS INTENDED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM COMPRESSION/DISTRACTION RACK 5.5. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15133488 ↗
• MalfunctionJul 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT THE COMPRESSION/ DISTRACTION RACK WAS STUCK AND COULDN´T MOVE. SURGERY WAS DELAY FOR 10 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE IS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) VIPER3D COMPRESSOR/DISTRACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065857 ↗
• MalfunctionMay 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, WHEN THE SPECIALIST WAS ASSEMBLING THE DISTRACTOR COMPRESSOR, IT IS RELEASED FROM THE SLEEVES. NO PROCEDURE OR PATIENT STATUS IS KNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR A VIPER COMPRESSOR/DISTRACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345509 ↗
• MalfunctionMay 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, WHEN THE SPECIALIST WAS ASSEMBLING THE DISTRACTOR COMPRESSOR, IT IS RELEASED FROM THE SLEEVES. NO PROCEDURE OR PATIENT STATUS IS KNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR A VIPER COMPRESSOR/DISTRACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345481 ↗
• MalfunctionDec 22, 2021Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, THAT DURING AN INCOMING INSPECTION THE LOANER SET DEPARTMENT WAS NOTICED THAT THE INSTRUMENT¿S LOCKING SCREWS IS SEIZED UP. THERE WAS NO SURGERY AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) VIPER3D COMPRESSOR/DISTRACTOR. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13062784 ↗
• MalfunctionNov 11, 2021Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE RAIL HAS SLIPPED OVER THE GEARING AND NO LONGER BE MOVED BACK. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT HARM OR CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) VIPER3D COMPRESSOR / DISTRACTOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12796868 ↗
• MalfunctionNov 11, 2021Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE RAIL HAS SLIPPED OVER THE GEARING AND NO LONGER BE MOVED BACK. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT HARM OR CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) VIPER3D COMPRESSOR/DISTRACTOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12796862 ↗
• MalfunctionNov 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN SPINAL PROCEDURE, TWO (2) VIPER3D COMPRESSOR/DISTRACTORS WERE STUCK AND UNABLE TO BE ADJUSTED. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER AVAILABLE INSTRUMENT. THIS REPORT IS FOR ONE (1) VIPER3D COMPRESSOR/DISTRACTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739541 ↗
• MalfunctionNov 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN SPINAL PROCEDURE, TWO (2) VIPER3D COMPRESSOR/DISTRACTORS WERE STUCK AND UNABLE TO BE ADJUSTED. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER AVAILABLE INSTRUMENT. THIS REPORT IS FOR ONE (1) VIPER3D COMPRESSOR/DISTRACTOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737998 ↗
• MalfunctionOct 28, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN INCOMING INSPECTION AT THE LOANER SET DEPARTMENT IT WAS NOTICED THAT THE COMPRESSION INSTRUMENT CANNOT BE TIGHTENED AND THE COGS ARE BLOCKING. THERE WAS NO SURGERY OR PATIENT IMPACT. NO FURTHER INFORMATION AVAILABLE. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE ROTATIONAL LOCKING SCREW ON THE SECONDARY BODY WAS JAMMED AND CANNOT BE LOOSENED. ALSO, THE PIVOTING SLEEVE WAS OBSERVED TO LOOSE AND CANNOT BE TIGHTENED. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM COMPRESSION/DISTRACTION RACK 5.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12713094 ↗
• MalfunctionAug 23, 2021Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING THE PROCEDURE, THE VIPER3D COMPRESSOR/DISTRACTOR JAMMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER COMPRESSOR/DISTRACTOR. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER3D COMPRESSOR/DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353378 ↗