VIPER 186717640Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034123462), received between Aug 5, 2019 and Dec 17, 2021 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW BROKE POST-OP. THE SCREW WAS IMPLANTED ON (B)(6) 2017. A REMOVAL PROCEDURE WAS PERFORMED ON (B)(6) 2021; HOWEVER, THE SCREW COULD NOT BE REMOVED BECAUSE A NECESSARY INSTRUMENT WAS NOT AVAILABLE FOR THE PROCEDURE. THIS REPORT INVOLVES (1) VIPER SYSTEM CANNULATED MONOAXIAL SCREW 5.5 X 6.0 X 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

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

  MAUDE report 13025525 ↗
• MalfunctionDec 16, 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, THE PATIENT UNDERWENT REMOVAL SURGERY DUE TO BREAKAGE OF THE MONOAXIAL SCREW. THE IMPLANT WAS ORIGINALLY PLACED IN THE PATIENT ON (B)(6) 2017. IT WAS FOUND THAT THE HANDLE REQUIRED FOR REMOVAL WAS NOT DELIVERED BEFORE THE PROCEDURE. THE SURGEON USED A DIFFERENT UNKNOWN HANDLE INSTEAD BUT THE BROKEN SCREW COULD NOT BE REMOVED AS THE HANDLE DID NOT REACH THE SCREW. THE SURGERY WAS ENDED WITH THE SCREW REMAINING IN THE PATIENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS RELATED TO (B)(4). THIS REPORT IS FOR ONE (1) VIPER SYSTEM CANNULATED MONOAXIAL SCREW 5.5 X 6.0 X 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019766 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. IT WAS DETERMINED THERE WAS NO REPORTED OR IDENTIFIED MALFUNCTION OF THE DEVICE.

  Patient problems: No Code Available; Pain

  MAUDE report 8861376 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOSPITAL - (B)(6). DATE OF COMPLAINT - (B)(6) 2019. MADE AWARE - (B)(4) 2019. PRESENT IN THEATRE - YES. DELAY IN PROCEDURE - NONE. IMPACT TO PATIENT - PAIN LEADING TO PLANNED REVISION PROCEDURE. PRODUCT CODE (1)- 186717640 X 4, LOT NO. UNKNOWN AT THIS TIME; PRODUCT CODE (2) - 186715640 X 2; PRODUCT CODE (3) - ROD, CODE/LOT NO UNKNOWN; PRODUCT CODE (4) - 186715000 X 6, LOT NO. UNKNOWN AT THIS TIME. AM I IN POSSESSION - AWAITING STERILISATION/DECON CERTIFICATE. WHAT HAPPENED - REVISION SURGERY TO REMOVE METALWORK. REVISION / HARDWARE REMOVAL . DATE OF ORIGINAL IMPLANT: APPROX 12 MONTHS. WAS DEVICE EXPLANTED (YES OR NO): YES. IF YES, DATE OF EXPLANT: (B)(6) 2019. REVISION DUE TO: PAIN, BROKEN METALWORK (PEDICLE SCREWS). HARDWARE REMOVAL DUE TO: BROKEN METALWORK - DISTAL 2 PEDICLE SCREWS. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES.

  Patient problems: No Code Available; Pain

  MAUDE report 8861322 ↗
• InjuryAug 5, 2019Break; Break

  HOSPITAL - (B)(6). DATE OF COMPLAINT - (B)(6) 2019. MADE AWARE - (B)(4) 2019. PRESENT IN THEATRE - YES. DELAY IN PROCEDURE - NONE. IMPACT TO PATIENT - PAIN LEADING TO PLANNED REVISION PROCEDURE. PRODUCT CODE (1)- 186717640 X 4, LOT NO. UNKNOWN AT THIS TIME. PRODUCT CODE (2) - 186715640 X 2. PRODUCT CODE (3) - ROD, CODE/LOT NO UNKNOWN. PRODUCT CODE (4) - 186715000 X 6, LOT NO. UNKNOWN AT THIS TIME. AM I IN POSSESSION - AWAITING STERILISATION/DECON CERTIFICATE. WHAT HAPPENED - REVISION SURGERY TO REMOVE METALWORK. REVISION / HARDWARE REMOVAL. DATE OF ORIGINAL IMPLANT: APPROX 12 MONTHS . WAS DEVICE EXPLANTED (YES OR NO): YES. IF YES, DATE OF EXPLANT: (B)(6) 2019. REVISION DUE TO: PAIN, BROKEN METALWORK (PEDICLE SCREWS). HARDWARE REMOVAL DUE TO: BROKEN METALWORK - DISTAL 2 PEDICLE SCREWS. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES.

  Patient problems: No Code Available; Pain

  MAUDE report 8861176 ↗
• InjuryAug 5, 2019Break; Break

  HOSPITAL - (B)(6). DATE OF COMPLAINT - (B)(6) 2019. MADE AWARE - (B)(4) 2019. PRESENT IN THEATRE - YES. DELAY IN PROCEDURE - NONE. IMPACT TO PATIENT - PAIN LEADING TO PLANNED REVISION PROCEDURE. PRODUCT CODE (1)- 186717640 X 4, LOT NO. UNKNOWN AT THIS TIME. PRODUCT CODE (2) - 186715640 X 2. PRODUCT CODE (3) - ROD, CODE/LOT NO UNKNOWN. PRODUCT CODE (4) - 186715000 X 6, LOT NO. UNKNOWN AT THIS TIME. AM I IN POSSESSION - AWAITING STERILISATION/DECON CERTIFICATE. WHAT HAPPENED - REVISION SURGERY TO REMOVE METALWORK. REVISION / HARDWARE REMOVAL. DATE OF ORIGINAL IMPLANT: APPROX 12 MONTHS. WAS DEVICE EXPLANTED (YES OR NO): YES. IF YES, DATE OF EXPLANT: (B)(6) 2019. REVISION DUE TO: PAIN, BROKEN METALWORK (PEDICLE SCREWS). HARDWARE REMOVAL DUE TO: BROKEN METALWORK - DISTAL 2 PEDICLE SCREWS. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES.

  Patient problems: No Code Available; Pain

  MAUDE report 8861066 ↗