VIPER PRIME 186770445SRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705034530253), received between Sep 27, 2018 and May 28, 2025 — classified as 10 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD LUMBER DECOMPRESSION AND SPINAL FIXATION SURGERY AT L4-S1 IN (B)(6) 2023. THE PATIENT CAME BACK TO THE SURGERY CLINIC FOR FOLLOW-UP AFTER SUFFERING FROM SEVERE LOWER LIMBS PAIN AND NUMBNESS. THE PATIENT HAD MRI BASED ON SURGEON REQUEST TO DIAGNOSE AND INVESTIGATE FOR THE REASON, AND THE SURGEON FOUND THE BILATERAL SCREWS AT S1 HAD BEEN BROKEN, SO IMMEDIATELY THE SURGEON ADMITTED THE PATIENT FOR REVISION SURGERY TO REMOVE AND REPLACED THE BROKEN SCREWS WITH NEW ONES.

  Patient problems: Numbness; Pain

  MAUDE report 22094521 ↗
• InjuryMay 28, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD LUMBER DECOMPRESSION AND SPINAL FIXATION SURGERY AT L4-S1 IN (B)(6) 2023. THE PATIENT CAME BACK TO THE SURGERY CLINIC FOR FOLLOW-UP AFTER SUFFERING FROM SEVERE LOWER LIMBS PAIN AND NUMBNESS. THE PATIENT HAD MRI BASED ON SURGEON REQUEST TO DIAGNOSE AND INVESTIGATE FOR THE REASON, AND THE SURGEON FOUND THE BILATERAL SCREWS AT S1 HAD BEEN BROKEN, SO IMMEDIATELY THE SURGEON ADMITTED THE PATIENT FOR REVISION SURGERY TO REMOVE AND REPLACED THE BROKEN SCREWS WITH NEW ONES.

  Patient problems: Numbness; Pain

  MAUDE report 22094520 ↗
• InjuryMay 28, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD LUMBER DECOMPRESSION AND SPINAL FIXATION SURGERY AT L4-S1 IN (B)(6) 2023. THE PATIENT CAME BACK TO THE SURGERY CLINIC FOR FOLLOW-UP AFTER SUFFERING FROM SEVERE LOWER LIMBS PAIN AND NUMBNESS. THE PATIENT HAD MRI BASED ON SURGEON REQUEST TO DIAGNOSE AND INVESTIGATE FOR THE REASON, AND THE SURGEON FOUND THE BILATERAL SCREWS AT S1 HAD BEEN BROKEN, SO IMMEDIATELY THE SURGEON ADMITTED THE PATIENT FOR REVISION SURGERY TO REMOVE AND REPLACED THE BROKEN SCREWS WITH NEW ONES.

  Patient problems: Numbness; Pain

  MAUDE report 22094517 ↗
• InjuryMay 28, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD LUMBER DECOMPRESSION AND SPINAL FIXATION SURGERY AT L4-S1 IN (B)(6) 2023. THE PATIENT CAME BACK TO THE SURGERY CLINIC FOR FOLLOW-UP AFTER SUFFERING FROM SEVERE LOWER LIMBS PAIN AND NUMBNESS. THE PATIENT HAD MRI BASED ON SURGEON REQUEST TO DIAGNOSE AND INVESTIGATE FOR THE REASON, AND THE SURGEON FOUND THE BILATERAL SCREWS AT S1 HAD BEEN BROKEN, SO IMMEDIATELY THE SURGEON ADMITTED THE PATIENT FOR REVISION SURGERY TO REMOVE AND REPLACED THE BROKEN SCREWS WITH NEW ONES.

  Patient problems: Numbness; Pain

  MAUDE report 22094516 ↗
• InjuryJan 30, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT A SURGERY WITH THE VBSS AND PRIME FSS WAS PERFORMED ON (B)(6) 2024. THE PRIME FSS WERE INSERTED INTO THE VERTEBRAL BODIES ABOVE AND BELOW WHERE THE VBSS WERE PLACED. SHORT SCREWS WERE ALSO INSERTED INTO WHERE THE VBSS WERE PLACED. AFTER THE SURGERY, FEVER, INFECTION ETC. WERE OBSERVED, AND THE IMPLANTS WERE LOOSE, SO A REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2025. SINCE THE CYST HAD ACCUMULATED IN THE PSOAS MAJOR MUSCLE, DEBRIDEMENT WAS ALSO DONE IN THE REMOVAL SURGERY. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND THE SURGEON IS KEEPING TRACK OF THE INFECTION CONDITION IN ORDER TO PLAN THE NEXT REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE. COMPLAINTS (B)(4) ARE RELATED COMPLAINTS. (B)(4) (SYNTHES SPINE): VBS AND (B)(4) (DEPUY SPINE): PRIME FS REPORT ABOUT THE SAME EVENT OCCURRED AFTER THE INITIAL SURGERY. (B)(4) REPORTS ABOUT THE EVENT OCCURRED DURING THE REMOVAL SURGERY.

  Patient problems: Cyst(s); Fever; Unspecified Infection

  MAUDE report 21275216 ↗
• InjuryJan 30, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT A SURGERY WITH THE VBSS AND PRIME FSS WAS PERFORMED ON (B)(6) 2024. THE PRIME FSS WERE INSERTED INTO THE VERTEBRAL BODIES ABOVE AND BELOW WHERE THE VBSS WERE PLACED. SHORT SCREWS WERE ALSO INSERTED INTO WHERE THE VBSS WERE PLACED. AFTER THE SURGERY, FEVER, INFECTION ETC. WERE OBSERVED, AND THE IMPLANTS WERE LOOSE, SO A REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2025. SINCE THE CYST HAD ACCUMULATED IN THE PSOAS MAJOR MUSCLE, DEBRIDEMENT WAS ALSO DONE IN THE REMOVAL SURGERY. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND THE SURGEON IS KEEPING TRACK OF THE INFECTION CONDITION IN ORDER TO PLAN THE NEXT REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE. COMPLAINTS (B)(4) ARE RELATED COMPLAINTS. (B)(4) (SYNTHES SPINE): VBS AND (B)(4) (DEPUY SPINE): PRIME FS REPORT ABOUT THE SAME EVENT OCCURRED AFTER THE INITIAL SURGERY. (B)(4) REPORTS ABOUT THE EVENT OCCURRED DURING THE REMOVAL SURGERY.

  Patient problems: Cyst(s); Fever; Unspecified Infection

  MAUDE report 21275208 ↗
• MalfunctionAug 13, 2024Compatibility Problem; Material Twisted/Bent; Compatibility Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THIS WAS A LUMBAR SPINE FUSION (L5-S1) PERFORMED ON AN UNKNOWN DATE. IT IS UNKNOWN WHETHER THE JJ PRODUCTS WERE USED IN THE INITIAL SURGERY OR NOT. THE SECOND SURGERY WAS PERFORMED FOR EXTENSION FIXATION. THE CAUSE OF THE SECOND SURGERY IS UNKNOWN. IN THE SURGERY, THE OTHER COMPANY¿S CAGES WERE INSERTED AT L3/4 AND L4/5 VIA AN ANTERIOR APPROACH. AFTER L5-S1 SCREWS REMOVAL, EXTENSION FIXATION TO L3-S1 WAS PERFORMED. AFTER REMOVAL OF A SCREW THAT HAD BEEN INSERTED IN THE INITIAL SURGERY, WHEN THE SURGEON ATTEMPTED TO INSERT THE SCREW IN QUESTION, THE SCREW BEHAVED AS IF IT WAS SPINNING. AFTER CHECKING THE RETIGHTENING OF THE INSTRUMENT, WHICH DID NOT IMPROVE THE SITUATION, ANOTHER PRODUCT OF THE SAME SIZE WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFN XTB 7X45MM S THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978162 ↗
• InjuryJan 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: 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 FAILURE. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 45MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18466474 ↗
• MalfunctionSep 14, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION FOR A LUMBAR DEGENERATIVE DISEASE ON (B)(6) 2023. THE SURGEON TRIED TO ATTACH THE SCREW TO THE SCREWDRIVER, BUT NO MATTER HOW MANY TIMES HE TRIED, THE BLACK LINE ON THE SCREWDRIVER, WHICH SERVES AS A GUIDE FOR ATTACHMENT, AND THE BLACK LINE ON THE TAB DID NOT ALIGN ALL THE WAY TO THE END, AND HE COULD NOT ATTACH THE SCREW SECURELY TO THE SCREWDRIVER. OTHER STAFF ALSO TRIED TO ATTACH THE SCREW TO THE SCREWDRIVER, BUT THEY COULDN¿T ATTACH THEM. THE SURGEON HAD NO CHOICE BUT TO ATTACH ANOTHER SCREW WITH THE SAME SIZE TO THE SCREWDRIVER AND INSERTED THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. ALL SCREWS EXCEPT THE ONE IN QUESTION WERE FIRMLY ATTACHED TO THAT SCREWDRIVER. AFTER SURGERY, THE SALE REP ALSO TRIED TO ATTACH THE SCREW TO THE SCREWDRIVER, BUT HE COULDN¿T. PATIENT OUTCOME/STATUS WAS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVERS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFN XTB 7X45MM S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744520 ↗
• MalfunctionSep 13, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PLIF (L3) FOR STENOSIS ON (B)(6) 2023. THE SCREW IN QUESTION COULD NOT BE ATTACHED TO A SCREWDRIVER. THE SCREWDRIVER DID NOT GO DEEP ENOUGH, PERHAPS BECAUSE THE HOLE IN THE CORE OF THE SCREW HEAD WAS TOO SMALL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736457 ↗
• MalfunctionJun 2, 2023Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED DURING A SURGERY ON (B)(6) 2023, THE MATCHING RECESS FOR THE VIPER PRIME SCREWDRIVER IS MISSING IN THE SCREW. THEREFORE THE IMPLANT COULD NOT BE IMPLANTED. THERE WAS NO PATIENT HARM AND A NEW ADDITIONAL SCREW HAD TO BE OPENED. A 5 MINUTE SURGICAL DELAY WAS NOTED. PROCEDURE COMPLETED SUCCESSFULLY. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR (1) VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 45MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049803 ↗
• MalfunctionJun 2, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED DURING A SURGERY ON (B)(6) 2023, THE MATCHING RECESS FOR THE VIPER PRIME SCREWDRIVER IS MISSING IN THE SCREW. THEREFORE THE IMPLANT COULD NOT BE IMPLANTED. THERE WAS NO PATIENT HARM AND A NEW ADDITIONAL SCREW HAD TO BE OPENED. A 5 MINUTE SURGICAL DELAY WAS NOTED. PROCEDURE COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR (1) VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 45MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049753 ↗
• MalfunctionMar 30, 2023Break; Mechanical Problem; Break; Mechanical Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A FUSION (L5/S) PERFORMED ON (B)(6) 2023. THE SURGEON INSERTED ALL THE SCREWS AND TIGHTENED RODS, BUT ONLY THE SET SCREW FOR S1 WAS NOT TIGHTENED PROPERLY. THE SURGEON USED A NEW SET SCREW, BUT IT WAS NOT TIGHTENED PROPERLY EITHER. THEREFORE, THE SURGEON REPLACED THE FENESTRATED SCREW IN QUESTION WITH A NEW ONE, AND THE SET SCREW WAS TIGHTENED SUCCESSFULLY. THE SURGEON COMMENTED THAT THE THREADS ON THE FENESTRATED SCREW MIGHT HAVE BEEN BROKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 45MM. THIS IS REPORT 1 OF 1 FOR PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644045 ↗
• MalfunctionJan 22, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN MIS PROCEDURE WITH VIPER PRIME ON (B)(6) 2019, A SCREW BECAME STUCK IN THE SCREWDRIVER AND COULD NOT BE REMOVED. THE STYLET WAS ALSO STUCK. THE SURGEON NEEDED TO USE OTHER DEVICES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF TWENTY (20) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A VIPER PRIME SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9615942 ↗
• MalfunctionApr 26, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE VIPER PRIME SCREW SADDLE DISLODGED FROM SCREW TULIP. REMOVED AND NEW SCREW INSERTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8557337 ↗
• InjuryDec 5, 2018Disconnection; Loose or Intermittent Connection; Material Split, Cut or Torn; Disconnection; Loose or Intermittent Connection; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRIME SCREW FROM (B)(6) 2018 MONDAY REVISED AT WHICH THE SET SCREW HAD GONE OFF. EVEN WITH THE CLOTHESPIN COULD NOT PUSH THE ROD COMPLETELY IN THE HEAD. IT OBVIOUSLY TOOK 1-2 TURNS AND THE TORQUE WAS TRIGGERED INTRAOPERATIVELY, BUT THE STOP OF THE SET SCREW WAS JUST INADEQUATE. PLEASE FOR INVESTIGATION. THE SCREW IS READY FOR PICKUP TOMORROW. WE DO NOT HAVE ANY MUMBLING. WAS A TROUBLE-FREE SURGERY. I HAVE NOT NOTICED EITHER, BECAUSE YOU CANNOT SEE IT AND THE TORQUE KEY HAS BEEN TRIGGERED. PATIENCE CONSEQUENCE: YES, REVISION SURGERY.

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

  MAUDE report 8134447 ↗
• InjurySep 27, 2018Break; Break

  PLEASE REFER TO THE LOCAL DESCRIPTION: PATIENT CONSEQUENCE?: YES. PATIENT CONSEQUENCE DESCRIPTION: REVISIONS OP, 8 PEDIKELSCHRAUBEN STATT 4. ACTION TAKEN FOR PROCEDURE:ENTERING DER ABGEBROCHENEN VIPER PRIME SCHRAUBEN, EINBRINGEN VON 8 CFX SCHRAUBEN L4 BIS S2 UND ANSCHLIESSENDE ZEMENTAUGMENTATION. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Not Applicable

  MAUDE report 7915688 ↗
• InjurySep 27, 2018Break; Break

  PLEASE REFER TO THE LOCAL DESCRIPTION. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION: REVISIONS OP, "8 PEDIKELSCHRAUBEN STATT 4." ACTION TAKEN FOR PROCEDURE: "ENTFERNUNG DER ABGEBROCHENEN VIPER PRIME SCHRAUBEN, EINBRINGEN VON 8 CFX SCHRAUBEN L4 BIS S2 UND ANSCHLIESSENDE ZEMENTAUGMENTATION." IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Not Applicable

  MAUDE report 7915476 ↗