VIPER 179706890Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034266466), received between Jul 17, 2019 and Feb 3, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, REVISION SURGERY WAS SCHEDULE DUE TO A BROKEN ILIUM SCREW. PRIMARY SURGERY WAS DONE THREE(3) YEARS AGO, ONLY A PART OF THE BROKEN SCREW WAS REMOVED AND HE SCREW SHAFT REMAINED IN THE PATIENT'S BODY AND COULD NOT BE REMOVED. THIS REPORT IS FOR ONE (1) VIPER T27 ILIAC SCREW 8X90, TI. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 13440459 ↗
• InjuryJul 17, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT REVISION SURGERY. PATIENT HAT INITIAL TH10-S2 SPINAL FUSION SURGERY IN (B)(6) 2019 WITH TWO CAGES (GLOBUS ALTERA) AT L4/5 AND L5/S1) AND EXPEDIUM VERSE CLASSIC SCREWS AT LEVEL AND A S2 VIPER T27 RILIAC SCREWS AT LEVEL S2 (8X90MM). ROD SLIPPAGE AT LEVEL S2 IN VIPER T27 REVISION SCREWS APP. 2 MONTHS AFTER INITIAL SURGERY. REVISION SURGERY HAT TO BE DONE IN JUNE 2019. DURING REVISION SURGERY, THE SURGEON NOTICED THAT BOTH INNIES OF THE S2 VIPER T27 ILIAC SCREWS WERE TOTALLY LOOSE. FURTHERMORE, SCREW LOOSENING WAS OBSERVED AT SEVERAL LEVELS INCLUDING S2. SURGEON DECIDED TO REPLACE ALL SCREWS WITH NEW ONES (EXPEDIUM VERSE ADVANCED AND 9MM VIPER T27 REVISION SCREWS). SURGICAL DELAY IS UNKNOWN. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8798557 ↗
• InjuryJul 17, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT REVISION SURGERY. PATIENT HAT INITIAL TH10-S2 SPINAL FUSION SURGERY IN (B)(6) 2019 WITH TWO CAGES (GLOBUS ALTERA) AT L4/5 AND L5/S1) AND EXPEDIUM VERSE CLASSIC SCREWS AT LEVEL AND A S2 VIPER T27 RILIAC SCREWS AT LEVEL S2 (8 X 90 MM). ROD SLIPPAGE AT LEVEL S2 IN VIPER T27 REVISION SCREWS APP. 2 MONTHS AFTER INITIAL SURGERY. REVISION SURGERY HAT TO BE DONE IN (B)(6) 2019. DURING REVISION SURGERY, THE SURGEON NOTICED THAT BOTH INNIES OF THE S2 VIPER T27 ILIAC SCREWS WERE TOTALLY LOOSE. FURTHERMORE, SCREW LOOSENING WAS OBSERVED AT SEVERAL LEVELS INCLUDING S2. SURGEON DECIDED TO REPLACE ALL SCREWS WITH NEW ONES (EXPEDIUM VERSE ADVANCED AND 9 MM VIPER T27 REVISION SCREWS). SURGICAL DELAY IS UNKNOWN. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8798303 ↗