VIPER 186788045Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034131740), received between Nov 13, 2019 and Jan 8, 2024 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K071860, K111136); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 IS FOR DEPUY SYNTHES SPINE VIPER AND VIPER /OTHER PRODUCTS. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18465394 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: WOUND INFECTION DEEP, WOUND INFECTION SUPERFICIAL, COMPLICATION TIME/INTERVENTION, POSTOPERATIVE (BEFORE DISCHARGE). THIS IS FOR DEPUY SYNTHES SPINE VIPER /OTHER AND EXPEDIUM POLYAXIAL PRODUCTS (VIPER2 LORDOTIC ROD-45MM (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 18454431 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, AS SCHEDULED AND IT WAS COMPLETED WITH NO PROBLEMS. THE FOLLOWING PROCEDURES WERE DONE IN THE REVISION SURGERY. L3/4: XLIF WAS PERFORMED. L4/5: SET SCREWS AND RODS INSERTED IN THE INITIAL SURGERY WERE REMOVED. L2 AND L3: DIAMETER 6.0 - LENGTH 50 MM VIPER PRIME SCREWS WERE INSERTED. S: DIAMETER 6.0 - LENGTH 45 MM VIPER PRIME SCREW WAS INSERTED. L2/S: DIAMETER 5.5 MM VIPER ROD WAS INSERTED. SET SCREWS WERE INSERTED AND THE FINAL TIGHTENING WAS DONE.

  Patient problems: Osteolysis

  MAUDE report 17923237 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, AS SCHEDULED, AND IT WAS COMPLETED WITH NO PROBLEMS. THE FOLLOWING PROCEDURES WERE DONE IN THE REVISION SURGERY. L3/4: XLIF WAS PERFORMED. L4/5: SET SCREWS AND RODS INSERTED IN THE INITIAL SURGERY WERE REMOVED. L2 AND L3: DIAMETER 6.0 - LENGTH 50 MM VIPER PRIME SCREWS WERE INSERTED. S: DIAMETER 6.0 - LENGTH 45 MM VIPER PRIME SCREW WAS INSERTED. L2/S: DIAMETER 5.5 MM VIPER ROD WAS INSERTED. SET SCREWS WERE INSERTED AND THE FINAL TIGHTENING WAS DONE.

  Patient problems: Osteolysis

  MAUDE report 17923225 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PLIF (L4/L5) FOR SPINAL STENOSIS ON (B)(6) 2023. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, THE INFECTION OCCURRED. ON (B)(6) 2023, DEBRIDEMENT WILL BE DONE WITH THE INCISION OPENED UNDER GENERAL ANESTHESIA DUE TO INFECTION. DURING THIS TIME, SOME IMPLANTED PRODUCTS MAY BE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM ROD, PRE-LORDOSED 45MM. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16598338 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PLIF (L4/L5) FOR SPINAL STENOSIS ON (B)(6) 2023. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, THE INFECTION OCCURRED. ON (B)(6) 2023, DEBRIDEMENT WILL BE DONE WITH THE INCISION OPENED UNDER GENERAL ANESTHESIA DUE TO INFECTION. DURING THIS TIME, SOME IMPLANTED PRODUCTS MAY BE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM ROD, PRE-LORDOSED 45MM. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4) .

  Patient problems: Unspecified Infection

  MAUDE report 16598244 ↗
• MalfunctionDec 23, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A VIPER 2 50MM ROD WAS INSERTED INTO THE VIPER PRIME SCREWS, THE SET SCREWS WERE INSERTED AND TORQUED OFF, THE VIPER PRIME ROD HOLDER WAS REMOVED ACCORDING TO THE TECHNIQUE GUIDE. WHEN TAKING A FINAL INTRA-OP X-RAY, THE SURGEON DISCOVERED THAT THE VIPER 2 50MM ROD HAD BROKEN, AND A FRAGMENT OF THAT ROD WAS RETAINED IN THE PATIENT. UNDER FLUOROSCOPIC GUIDANCE, THE SURGEON CAREFULLY REMOVED THE FRAGMENT OF THE ROD, REMOVED ALL SET SCREWS, AND REMOVED THE ROD. A SECOND ROD WAS INSERTED USING THE SAME TECHNIQUE AS ABOVE. UPON A FINAL INTRA-OP X-RAY, THE SURGEON AGAIN NOTICED THAT THE VIPER ROD HAD BROKEN. BOTH TIMES, THIS HAPPENED AT THE CONNECTION POINT BETWEEN THE ROD AND THE ROD INSERTER INSTRUMENT. THE SECOND FAILURE RESULTED IN A SIMILAR BROKEN ROD FRAGMENT. THIS WAS REMOVED UNDER FLUOROSCOPIC GUIDANCE. THE REMAINING VIPER ROD REMAINED IN THE PATIENT AS IT WAS SECURED WITHIN THE CONSTRUCT, AND THE SURGEON DIDN¿T WANT TO PUT THE PATIENT THROUGH MORE TIME IN THE OR. TO THE BEST OF THE REPORTER¿S KNOWLEDGE, THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM ROD, PRE-LORDOSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16042127 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH ISSUES RELATED TO A PREVIOUS FUSION DONE AT (B)(6) HOSPITAL IN (B)(6) ON (B)(6) 2020 AND ALL THE HARDWARE WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS AN L4-5 RIGHT SIDED TLIF WITH VIPER PRIME AND CONDUIT PLIF CULTURES WERE TAKEN INTRA-OP FOR A SUSPECTED FUNGAL INFECTION. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) VIPER2 LORDOTIC ROD-45MM. THIS REPORT IS 5 OF 10 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11049317 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH ISSUES RELATED TO A PREVIOUS FUSION DONE AT (B)(6) ON (B)(6) 2020 AND ALL THE HARDWARE WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS AN L4-5 RIGHT SIDED TLIF WITH VIPER PRIME AND CONDUIT PLIF CULTURES WERE TAKEN INTRA-OP FOR A SUSPECTED FUNGAL INFECTION. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) VIPER2 LORDOTIC ROD-45MM. THIS REPORT IS 4 OF 10 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11049315 ↗
• MalfunctionNov 13, 2019Break; Break

  ON (B)(6) 2017, AN INITIAL TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) PROCEDURE WAS PERFORMED TO STABILIZE L4-5 AT A DIFFERENT HOSPITAL. ON (B)(6) 2019, THE SURGEON PERFORMED A TLIF REVISION PROCEDURE AND A PPS (PERCUTANEOUS PEDICLE SCREW) EXTENSION PROCEDURE TO TREAT SPINAL STENOSIS, STABILIZING L5-S1. THE POLY DRIVER (279734000) BROKE OFF AGAINST THE HIGHLY OSSIFIED BONE. THE SURGEON REMOVED THE FRAGMENT AND A SCREW AND COMPLETED THE PROCEDURE WITH REPLACEMENTS LESS THAN A 30-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9314687 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071860, K111136. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2015 · Apr 21, 2015 · Terminated
  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467