VIPER PRIME 186770450Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034509624), received between Oct 15, 2019 and Jul 20, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 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.

• MalfunctionJul 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS NOTED THE PATIENT STATUS WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10298487 ↗
• InjuryJan 15, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD SPINAL FUSION SURGERY. IMMEDIATELY AFTER THE SURGERY THE PATIENT FELT GOOD, BUT ONE WEEK AFTER, THE PATIENT WAS AT THE EMERGENCY ROOM WITH AN ALLERGIC REACTION. HE WAS GIVEN BENEDRYL AND SYMPTOMS IMPROVED. HIS CONDITION HAS DETERIORATED AND IN PAIN EVERY DAY. HE HAD A PRIOR SURGERY IN THE 1990S WHERE STAINLESS STEEL OR TITANIUM RODS AND SCREWS WERE IMPLANTED IN HIS HAND AND HAD TO BE REMOVED BECAUSE OF ALLERGIC REACTION THAT CAUSED THE SURGERY SITE NOT TO HEAL. UPON REMOVAL OF THE IMPLANTS, THE HAND HEALED. THE CURRENT SURGEON WAS NOTIFIED OF THE ISSUE WITH THE PRIOR SURGERY BUT INSISTED THAT MATERIALS HAD CHANGED SINCE THE 1990S AND THE POSSIBILITY OF AN ADVERSE REACTION WERE MINISCULE. BECAUSE OF THE PATIENT URGED THE SURGEON TO GET HIM ALLERGY TESTED BECAUSE OF HOW HE FEELS, HE DID PUT IN AN ORDER AND WAS TESTED, HOWEVER, UPON COMPLETION OF THE TESTING HE WAS TOLD HE WAS TESTED FOR THE WRONG ITEMS. THE PATIENT HAVE NOT HEARD BACK FROM ANYONE AND NOW TAKING HIS HEALTHCARE INTO HIS OWN HANDS AND WOULD LIKE TO HAVE INDEPENDENT ALLERGY TESTING PERFORMED. THE PATIENT NEEDS INFORMATION FROM THE COMPANY IN ORDER TO DO SO. THIS IS REP

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 9590994 ↗
• InjuryJan 15, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD SPINAL FUSION SURGERY. IMMEDIATELY AFTER THE SURGERY THE PATIENT FELT GOOD, BUT ONE WEEK AFTER, THE PATIENT WAS AT THE EMERGENCY ROOM WITH AN ALLERGIC REACTION. HE WAS GIVEN BENEDRYL AND SYMPTOMS IMPROVED. HIS CONDITION HAS DETERIORATED AND IN PAIN EVERY DAY. HE HAD A PRIOR SURGERY IN THE 1990S WHERE STAINLESS STEEL OR TITANIUM RODS AND SCREWS WERE IMPLANTED IN HIS HAND AND HAD TO BE REMOVED BECAUSE OF ALLERGIC REACTION THAT CAUSED THE SURGERY SITE NOT TO HEAL. UPON REMOVAL OF THE IMPLANTS, THE HAND HEALED. THE CURRENT SURGEON WAS NOTIFIED OF THE ISSUE WITH THE PRIOR SURGERY BUT INSISTED THAT MATERIALS HAD CHANGED SINCE THE 1990S AND THE POSSIBILITY OF AN ADVERSE REACTION WERE MINISCULE. BECAUSE OF THE PATIENT URGED THE SURGEON TO GET HIM ALLERGY TESTED BECAUSE OF HOW HE FEELS, HE DID PUT IN AN ORDER AND WAS TESTED, HOWEVER, UPON COMPLETION OF THE TESTING HE WAS TOLD HE WAS TESTED FOR THE WRONG ITEMS. THE PATIENT HAVE NOT HEARD BACK FROM ANYONE AND NOW TAKING HIS HEALTHCARE INTO HIS OWN HANDS AND WOULD LIKE TO HAVE INDEPENDENT ALLERGY TESTING PERFORMED. THE PATIENT NEEDS INFORMATION FROM THE COMPANY IN ORDER TO DO SO. THIS IS REP

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 9590963 ↗
• MalfunctionOct 15, 2019Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  THE PHYSICIAN INDICATED THAT SCREW SHAFT WAS INSIDE THE CUP AND THEREFORE IT WAS IMPOSSIBLE TO IMPLEMENT THE ROD. THERE WERE NO CONSEQUENCES TO THE PATIENT REPORTED. THERE WAS SURGICAL DELAY OF 15 TO 20 MINUTES, FRAGMENTS WERE GENERATED HOWEVER THEY WERE EASILY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9193473 ↗