VIPER 179704980Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034265841), received between Oct 31, 2019 and Sep 16, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024Migration; Migration

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223275 ↗
• InjuryFeb 16, 2022Device Slipped; Migration; Device Slipped; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL PROCEDURE DUE TO SEVERE PUS IN THE LESION. DURING THE REMOVAL PROCEDURE THE SETSCREW CHIPPED. THE SURGEON REMOVED TWO FRAGMENTS FROM THE PATIENT¿S LESION. NO MORE FRAGMENTS WERE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THE PATIENT RECEIVED THE IMPLANTS ON (B)(6) 2015 AND THE BONE FUSION HAD NOT BEEN ATTAINED AT THE TIME OF THE REMOVAL SURGERY. THIS REPORT INVOLVES ONE (1) VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 9 X 80MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Purulent Discharge

  MAUDE report 13543354 ↗
• 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) VIPER TI SAI POLY 9X80 MM. THIS REPORT IS 1 OF 7 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12319694 ↗
• InjuryOct 31, 2019Break; Break

  DURING THE REMOVAL OF A DEPUY SYNTHES SPINE CONSTRUCT THE LEFT SIDE 9X80MM SAI SCREW (179704980) SHANK BROKE OFF AND REMAINS IN THE PATIENTS ILIAC SPINE. ONLY THE SCREW TULIP AND A PORTION OF THE SCREW SHANK WAS REMOVED. (PHOTO AVAILABLE). THE SCREW MIGHT HAVE ALREADY FRACTURED PRIOR TO REMOVAL. IF OTHER, DESCRIBE: REMOVAL OF CONSTRUCT DUE TO FUSION ACHIEVED AND SCREW PROMINENCE, PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NIL, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: HOSPITAL, DEVICE IN POSSESSION OF: DISPOSED. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 9261985 ↗