VIPER 186731850Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034352206), received between Jan 26, 2018 and Nov 5, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Break; Break

  IT WAS REPORTED THAT THIS WAS A PLIF (L5) PERFORMED ON (B)(6) 2022. THIS WAS A SECOND SURGERY TO REMOVE AND REPLACE THE L3-5 SCREWS THAT HAD BEEN INSERTED DURING THE PRIMARY SURGERY (XLIF). THE DATE OF THE PRIMARY SURGERY AND PRODUCT INFORMATION WERE UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, IT WAS CONFIRMED THAT THE L5 SCREW (VERSE CANNULATED CFX SCREW) WAS BROKEN. THEREFORE, A REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2025, AND THE SCREW WILL BE REPLACED WITH SCREW FROM ANOTHER COMPANY.

  Patient problems: Insufficient Information

  MAUDE report 23478735 ↗
• MalfunctionOct 4, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL INTERBODY FUSION (L4/5) ON (B)(6) 2023. AFTER SURGERY, ADJACENT SEGMENT DISEASE OCCURRED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. IN THE REVISION SURGERY, SCREWS AT L4/5 WERE REMOVED, L4-5 INTERVERTEBRAL DISCS WERE DISSECTED, A CAGE WAS INSERTED, AND A PPS (PERCUTANEOUS PEDICLE SCREW) (L3-5) WAS PERFORMED. AFTER INSERTING THE CAGE, SCREWS WERE INSERTED INTO BOTH SIDES OF L3, AND ANOTHER SCREW WAS INSERTED INTO THE RIGHT SIDE OF L4. AT THIS TIME, ORIGINALLY A 7MM DIAMETER CFS WAS IN PLACE, SO THE SCREW HOLE WAS WIDENED WITH 8MM DIAMETER AND THE CFS 8MM SCREW WAS INSERTED PERCUTANEOUSLY USING THE UNIVERSAL POLY SCREWDRIVER. BUT THE PATIENT¿S BONE QUALITY WAS HARD, AND THE UNIVERSAL POLY SCREWDRIVER SEEMED TO GET IDLED AT THE END OF THE INSERTION. THEREFORE, THE SALES REP ASKED THE SURGEON TO REMOVE THE UNIVERSAL POLY SCREWDRIVER. IT WAS FOUND THAT THE TIP OF THE UNIVERSAL POLY SCREWDRIVER WAS MISSING WHEN IT WAS CHECKED. IT WAS ASSUMED THAT THE TIP OF THE UNIVERSAL POLY SCREWDRIVER REMAINED IN THE SCREW CORE OF THE CFS 8MM SCREW, AND ALTHOUGH ATTEM

  Patient problems: Insufficient Information

  MAUDE report 17867756 ↗
• InjuryJun 15, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS REVISING A PATIENT WITH EXPEDIUM 5.5 IMPLANTS (CONSTRUCT BILATERALLY FROM T11-PELVIS) ORIGINALLY IMPLANTED ON (B)(6) 2018. THE PATIENT SUFFERED FROM PSEUDOARTHROSIS, WITH THE APPEARANCE OF PEDICLE SCREWS LOOSENING AT T11 AND L1 (BILATERALLY), S1 (RIGHT PEDICLE) AND BILATERAL S2 ILIAC BOLTS. THE SET SCREWS AT L5, S1 AND THE ILIAC SCREW ON THE PATIENT'S LEFT SIDE LOOSENED, AND THE S1 SET SCREW HAD BECOME DISLODGED FROM THE POLYAXIAL HEAD. THE SURGEON REMOVED THE T11 AND L1 PEDICLE SCREW BILATERALLY AND REPLACED EACH WITH 7.5 X 45MM SCREW. BEFORE PLACING THE NEW PEDICLE SCREW, THE SURGEON TAPPED THE ORIGINAL SCREW TRAJECTORY THE FULL LENGTH OF THE NEW SCREW (45MM) WITH A 7MM TAP AND PLACED THE NEW SCREWS SUCCESSFULLY. THE SURGEONS THEN REMOVED THE S1 PEDICLE SCREW ON THE RIGHT SIDE (7.5 X 45MM SCREW). THE SURGEON FELT THE PATHWAY OF THE REMOVED SCREW AND USED THE PEDICLE PROBE TO FURTHER CANNULATE S1 (R) TO THE ANTERIOR CORTEX AT 50MM AND DETERMINED IT WOULD BE REPLACED WITH AN 8.0 X 50MM SCREW FOR ADEQUATE PURCHASE. THEY THEN USED AN 8.0MM TAP TO TAP THE FULL LENGTH OF THE SCREW, 50MM AND CONFIRMED THE DEPTH WITH A BALL TIP PROBE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10153749 ↗
• MalfunctionDec 26, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS REVISING AN L5-S1 CONSTRUCT BY REMOVING THE EXISTING HARDWARE. THEY REMOVED NON-DEPUY HARDWARE FROM ALL FOUR (4) PEDICLES AND REMOVED SPECIFICALLY A BROKEN 7.5X50MM SCREW FROM THE RIGHT SIDES S1 PEDICLE. WHEN THEY WERE INSERTING A VIPER CORTICAL FIXATION 8X50MM SCREW INTO THE UNTAPPED PEDICLE, THE SCREWDRIVER BROKE OFF IN THE HEAD OF THE SCREW. THE SURGEON ATTEMPTED TO HELICOPTER THE SCREW OUT WITH A CUSTOM INSTRUMENT THAT HAD A ROD BUILT INTO IT. THE HEAD OF THE SCREW SIMPLY SPUN IN PLACE AND EVENTUALLY BROKE FREE. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. FRAGMENTS WERE GENERATED AND WERE EASILY REMOVED. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE OUTCOME WAS UNKNOWN. THIS REPORT IS FOR A VIPER CORTICAL FIXATION SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9520756 ↗
• InjurySep 26, 2019Break; Break

  IT WAS REPORTED THAT THIS WAS A PLIF (POSTERIOR LUMBAR INTERBODY FUSION) PROCEDURE TREATING SPINAL STENOSIS WITH L4-5 STABILIZATION ON (B)(6) 2019. WHILE THE SURGEON WAS INSERTING THE SCREW (186731850) WITH THE SCREWDRIVER (279751002) UP TO APPROXIMATELY 25MM INTO THE L5 LEFT, S/HE FELT EXCESSIVE TORQUE AND WAS NOT ABLE TO INSERT IT FURTHER. ALTHOUGH THE SURGEON TRIED TO RETRACT THE SCREW, S/HE ENCOUNTERED ANOTHER EXCESSIVE TORQUE AND FOUND THAT THE SCREWDRIVER¿S TIP HAD BEEN BROKEN OFF. DURING THE TROUBLESHOOTING, THE SURGEON SAW METAL PARTICLES AROUND THE SCREW¿S HEAD. WHILE THOSE PARTICLES WERE BEING REMOVED, THE SCREWHEAD CAME OFF, LEAVING THE BONE SCREW IN THE BONE. THE FRAGMENTED SCREWDRIVER¿S TIP REMAINS IN THE PATIENT¿S BODY, TOO. IT WAS CONFIRMED BY IMAGING THAT THE METAL PARTICLES HAD BEEN REMOVED. THE PROCEDURE WAS DELAYED FOR 60 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9122596 ↗
• MalfunctionJan 26, 2018Break; Break

  ON (B)(6) 2018, THE SURGERY FOR SPINAL CANAL STENOSIS WAS PERFORMED BY USING THE EXPEDIUM CONCORDE SYSTEM. THE FIXED AREA WAS L3 ¿ S. WHEN THE SCREW IN QUESTION WAS INSERTED, THE SCREW WAS STUCK AND DID NOT MOVE FORWARD OR BACKWARD IN THE MIDDLE SINCE THE VERTEBRAL BODY WAS HARD, AND THE TORQUE FOR SCREW INSERTION WAS STRONG. BECAUSE OF THAT, WHILE THE SURGEON WAS TRYING TO REMOVE THE SCREW, THE TIP OF TWO SCREW DRIVERS IN QUESTION WAS STRIPPED, AND THE TIP OF ONE SCREW DRIVER IN QUESTION WAS BROKEN. THE BROKEN TIP OF THE SCREW DRIVER IN QUESTION HAD BEEN LEFT IN THE CORE PART OF THE SCREW. REGARDING THE SCREW (CFS 8X50MM) WHICH WAS STUCK IN THE MIDDLE, THE SURGEON TRIED TO REMOVE IT IN SEVERAL WAYS AFTER ONE OF THE SCREW DRIVERS WAS BROKEN. SINCE THE SAME MANEUVER FOR REMOVING THE SCREW WAS DONE REPEATEDLY, THE HEAD OF THE SCREW IN QUESTION WAS BROKEN, AND THE THREAD PART OF THE SCREW IN QUESTION WAS LEFT IN THE PATIENT. IN ORDER TO REMOVE THE THREAD PART OF THE SCREW IN QUESTION, THE 4.75 POWER GRIP ROD HOLDER IN QUESTION WAS USED. ALTHOUGH THE SURGEON TRIED TO REMOVE THE SCREW THREAD, THE TIP OF THE ROD HOLDER WAS BENT. AS A RESULT, THE THREAD PART OF THE SCREW IN QUESTION COULD

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7222663 ↗