VIPER PRIME 186770445Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034509617), received between Mar 27, 2019 and Jan 5, 2024 — classified as 6 injuries, 5 malfunctions.

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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2024Migration; Migration

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: IMPLANT MALPOSITION, KIDNEY / URINARY, COMPLICATION TIME/INTERVENTION, POSTOPERATIVE (BEFORE DISCHARGE). THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFEN XTAB 7X45MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18460100 ↗
• InjuryJul 29, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT UNDERWENT A REVISION SURGERY TO REPLACE TWO VIPER PRIME SCREWS THAT HAD BROKEN AT THE DISTAL TIPS. THE SURGEON USED TREPHINES AND A SCREW EXTRACTION DEVICE TO REMOVE AND REPLACE WITH LARGER SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE A OF A COMPETITOR¿S PRODUCT. THIS REPORT INVOLVES ONE (1) VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 45MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15131929 ↗
• InjuryJul 29, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT UNDERWENT A REVISION SURGERY TO REPLACE TWO VIPER PRIME SCREWS THAT HAD BROKEN AT THE DISTAL TIPS. THE SURGEON USED TREPHINES AND A SCREW EXTRACTION DEVICE TO REMOVE AND REPLACE WITH LARGER SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE A OF A COMPETITOR¿S PRODUCT. THIS REPORT INVOLVES ONE (1) VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 45MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15131890 ↗
• MalfunctionMay 21, 2020Break; Break

  CONCOMITANT DEVICES REPORTED: CONF INTRO NDLE, DIA, 11G 6" (PART NUMBER 283903611, LOT 244046, QUANTITY 1), VIPER PRIME INSERT DRIVE TUBE (PART NUMBER 286750034, LOT UNKNOWN, QUANTITY 2), VIPER PRIME INSERTER CARRIER (PART NUMBER 286750033, LOT UNKNOWN, QUANTITY 2), VIPER PRIME INSERTER HANDLE (PART NUMBER 286750032, LOT UNKNOWN, QUANTITY 2), PRIME STYLET DEPTH ADJUSTOR (PART NUMBER 286750041, LOT UNKNOWN, QUANTITY 2), VIPER PRIME INSERTER SHAFT (PART NUMBER 286750031, LOT UNKNOWN, QUANTITY 2), VIPER PRIME STYLET (PART NUMBER 286750200S, LOT UNKNOWN, QUANTITY 1).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10080321 ↗
• MalfunctionApr 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SLEEVE IN THE IN THE 3D HEAD HAD COME LOOSE. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFEN XTAB 7X45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9944370 ↗
• 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 9590977 ↗
• 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 BENADRYL 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 MINUSCULE. 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 9590957 ↗
• InjuryDec 20, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR (TLIF) PROCEDURE ON (B)(6) 2019, THE SCRUB NURSE HAD DIFFICULTY LOADING THE IMPLANT. THE SURGEON WAS ABOUT TO IMPLANT BUT NOTICED THE CAGE WAS NOT STRAIGHT; THE INTERFACE WITH INSERTER WAS NOT STRAIGHT AND IN ALIGNMENT WITH INSERTER. ANOTHER CONCORDE BULLET INSERTER WAS TRIED, BUT THE CAGE WAS STILL NOT STRAIGHT. ANOTHER IMPLANT HAD TO BE OPENED, WHICH LOADED CORRECTLY. SURGEON WAS GETTING S1 NERVE ROOT IRRITATION WITH NEUROMONITORING SO IMPLANTED AND REMOVED SECOND IMPLANT. HAD TO GET CT SCAN AND NAVIGATE REMAINING SCREWS. IT WAS ALSO REPORTED THAT A VIPER PRIME SCREWDRIVER WAS NOT ABLE TO RELEASE SCREW AND STYLET WAS BENT AND HAD TO BE CUT. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PATIENT IS RECOVERING WELL. CONCOMITANT DEVICES: SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN) THIS REPORT IS FOR A VIPER PRIME CFXFEN XTAB 7X45MM. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9504133 ↗
• MalfunctionDec 5, 2019Device Damaged by Another Device; Device Damaged by Another Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON STARTED INSERTING 7 X 45 MM SCREW INTO PEDICLE WITH 5 MM OF STYLET ADVANCED. AFTER TAPPING SCREWDRIVER OVER THE STYLET, THE SCREW KEPT SKIVING OFF AND THE SCREW BECAME LOOSE, AND NOT HOLDING ITS TRAJECTORY. UPON CLOSER INVESTIGATION IT LOOKED LIKE THE COCR SADDLE HAD BECOME LOOSE. BOTH SCREWDRIVER AND SCREW ARE AVAILABLE FOR COLLECTION. THIS IS A CONSIGNMENT VIPER PRIME SCREWDRIVER AND VIPER PRIME 7 X 45 MM SCREW. BOTH NEED REPLACING IMMEDIATELY TO BUDERIM PRIVATE CONSIGNMENT KIT. EXPEDIUM THORACIC PROBES, STRAIGHT WERE OPENED ON CONSIGNMENT AND LOAN TRAYS, BOTH WERE BENT AND NEEDED TO BE REPLACED. ALL ITEMS HAVE BEEN TAGGED. SURGERY WAS DELAYED 10 MINUTES DUE TO THE REPORTED EVENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9416713 ↗
• MalfunctionJul 25, 2019Disconnection; Disconnection

  VIPER PRIME T HANDLE CRACKED AND FELL APART IN SURGEONS HANDS WHILST INSERTING 7 X 45 MM VIPER PRIME SCREW. USED SAME LIKE PRODUCT TO COMPLETE PUTTING IN IMPLANT INTO PATIENT. A SEPARATE VIPER PRIME SCREW DID NOT INSERT INTO PATIENT CORRECTLY. ON CLOSER EXAMINATION, THE SCREW SEEMS LOOSE IN THE COCR SADDLE. USED SAME LIKE PRODUCT TO COMPLETE OPERATION. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT?: YES. IF YES, NUMBER OF MINUTES: 5. ACTION TAKEN WHEN EVENT OCCURRED?: USED SAME LIKE PRODUCTS. WAS PROCEDURE SUCCESSFULLY COMPLETED?: YES. WERE FRAGMENTS GENERATED?: NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION?: YES. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?: N/A. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: NO. IP-00629336: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-00629337: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS B

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8826484 ↗
• MalfunctionMar 27, 2019Disconnection; Disconnection

  (B)(6) HOSPITAL (B)(6) 2019: VIPER PRIME 7X45MM 186770445 SCREW WAS ABOUT TO BE INSERTED ON PATIENT AND WAS NOT RIGID, WAS LOOSE AND FLOPPY. FURTHER INVESTIGATION ILLUSTRATES THE COCR SADDLE OF THE SCREW BECAME DISENGAGED AND LOOSE OUT OF THE TULIP OF THE SCREW. DID THE EVENT OCCUR DURING STERILE PROCESSING? --> UNKNOWN, DID THE EVENT OCCUR DURING FIELD INSPECTION? --> UNKNOWN, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455623 ↗