EXPEDIUM VIPER 196789300Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705034295251), received between Jul 13, 2018 and Oct 5, 2023 — classified as 13 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

1 other recall cover devices cleared under the same FDA submission (K090648, 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. 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 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 A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) (L4/5) WAS PERFORMED ON (B)(6) 2018. AFTER THE INITIAL SURGERY, ADJACENT SEGMENT DISEASE OCCURRED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THIS REPORT INVOLVES ONE EXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 X 300MM. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE EVENTS OCCURRED IN THE REVISION SURGERY. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPLANTS INVOLVED IN THE EVENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 17878367 ↗
• InjuryOct 5, 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 A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) (L4/5) WAS PERFORMED ON (B)(6) 2018. AFTER THE INITIAL SURGERY, ADJACENT SEGMENT DISEASE OCCURRED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THIS REPORT INVOLVES ONE EXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 X 300MM. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE EVENTS OCCURRED IN THE REVISION SURGERY. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPLANTS INVOLVED IN THE EVENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 17878363 ↗
• MalfunctionAug 28, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE SCREW REPLACEMENT PERFORMED IN THE REVISION SURGERY ON (B)(6), 2021. THIS PC REPORTS ABOUT THE ROD BREAKAGE FOUND IN THE REMOVAL SURGERY ON (B)(6), 2023. IT WAS REPORTED THAT THIS WAS A PPS (L3-5) FOR A FRACTURE OF L4 ON (B)(6), 2021. AFTER THE INITIAL SURGERY, A REVISION SURGERY WAS PERFORMED ON (B)(6), 2021, AND THE VIPER MONOAXIAL SCREW 7×45 MM INSERTED INTO L3 RIGHT WAS REPLACED WITH A PRIME SCREW 7×45 MM. AFTER THE REVISION SURGERY, A REMOVAL SURGERY WAS PERFORMED ON (B)(6), 2023, BECAUSE BONE UNION WAS CONFIRMED. DURING THE REMOVAL SURGERY, IT WAS FOUND THAT THE ROD (196789300) THAT HAD BEEN INSTALLED ON THE LEFT SIDE WAS BROKEN JUST ABOVE THE SCREW AT L4. THE REMOVAL OF THE ROD ITSELF WAS DONE WITH NO PROBLEMS. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO IMPACT ON THE PATIENT DUE TO THE ROD BREAKAGE AND NO SYMPTOMS, ETC. THE EXACT DATE OF THE ROD BREAKAGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED - UNK - SCREWS: VIPER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633819 ↗
• MalfunctionSep 15, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED TO REMOVE OSTEOSYNTHESIS MATERIAL OF THE SPINE (EXPEDIUM 5.5 SYSTEM) BECAUSE ONE OF THE SCREWS IMPLANTED IN THE PATIENT BROKE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR AN EXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 X 300MM. THIS IS REPORT 6 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15428118 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF SCOLIOSIS FIXATION RANGING FROM T3-L1 ON (B)(6) 2022. THE LAST 2 CAUDAL SCREWS, ON BOTH SIDES, FOUND THEIR RESPECTIVE SETSCREWS LOOSENED. SURGEON DISCOVERED UNSTABLE MONTAGE AND METALLOSIS. FOUR SCREWS WERE REPLACED IN TOTAL AND THE FIXATION WAS EXTENDED BY ONE LEVEL CAUDALLY. THIS REPORT IS FOR AN UNKNOWN VIPER SCREW. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13584619 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF SCOLIOSIS FIXATION RANGING FROM T3-L1 ON (B)(6) 2022. THE LAST 2 CAUDAL SCREWS, ON BOTH SIDES, FOUND THEIR RESPECTIVE SETSCREWS LOOSENED. SURGEON DISCOVERED UNSTABLE MONTAGE AND METALLOSIS. FOUR SCREWS WERE REPLACED IN TOTAL AND THE FIXATION WAS EXTENDED BY ONE LEVEL CAUDALLY. THIS REPORT IS FOR AN UNKNOWN VIPER SCREW. THIS IS REPORT 8 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13584483 ↗
• MalfunctionDec 15, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, WHILE DOING THE FINAL LOCK, AFTER THE DEROGATION MANEUVER, THE SURGEON FOUND THAT THE ROD WAS NOT TIGHTLY BLOCKED INTO THE UNIPLANAR SCREW HEADS. THIS IN COMPARISON WITH THE UPPER AND LOWER POLY AXIAL SCREWS WITH THE FIXATION TO THE ROD WAS VERY SOLID. WITH THE UNIPLANAR SCREWS, ONE COULD CLEARLY SEE AN UNEXPECTED MEDIO-LATERAL MOVEMENT / DEGREE OF FREEDOM DESPITE AN AD-HOC TIGHTENING WITH THE TORQUE HANDLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN TORQUE DEVICE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) VIPER2 STRAIGHT ROD300MM, COCR. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13013431 ↗
• MalfunctionDec 7, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE DOING THE FINAL LOCK, AFTER THE DEROGATION MANEUVER, THE SURGEON FOUND THAT THE ROD WAS NOT TIGHTLY BLOCKED INTO THE UNIPLANAR SCREW HEADS. THIS IN COMPARISON WITH THE UPPER AND LOWER POLY AXIAL SCREWS WITH THE FIXATION TO THE ROD WAS VERY SOLID. WITH THE UNIPLANAR SCREWS, ONE COULD CLEARLY SEE AN UNEXPECTED MEDIO-LATERAL MOVEMENT / DEGREE OF FREEDOM DESPITE AN AD-HOC TIGHTENING WITH THE TORQUE HANDLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN TORQUE HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER UNI SCREW 5X35MM TI. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953843 ↗
• InjuryOct 16, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT T4-L3 PEDICLE SCREW FUSION WITH EXPEDIUM VERSE OF UNITIZED SET SCREWS & 300 MM COBALT CHROME RODS. THE PATIENT RETURNED TO CLINIC FOR POSTOPERATIVE VISIT COMPLAINING OF PAIN IN THE LUMBAR SPINE AREA. ANTERIOR/POSTERIOR (A/P) & LATERAL X-RAYS OBTAINED WHICH REVEALED THAT THE ROD WAS NO LONGER LOCKED IN PLACE ON THE RIGHT SIDE AT L3 & THAT THE HEAD OF THE RIGHT L3 SCREW WAS NO LONGER LOCKED IN PLACE. BASED ON THESE FINDINGS, THE SURGEON SCHEDULED THE PATIENT TO RETURN TO THE OR ON (B)(6) 2020 FOR REVISION OF THE ROD & UNITIZED SET SCREW. AFTER EXPOSURE, THE SURGEON REMOVED THE IMPLANTED UNITIZED SET SCREW, WHICH WAS STILL IN THE HEAD OF THE SCREW BUT LOOSE, PLACED THE COBALT CHROME ROD BACK INTO THE HEAD OF THE RIGHT L3 SCREW, PLACED A NEW UNITIZED SET SCREW, COMPRESSED & PERFORMED FINAL TIGHTENING TO THE RIGHT L3 UNITIZED SET SCREW. HE FURTHER CONFIRMED ROD PLACEMENT WITH AN A/P X-RAY & CLOSED THE INCISION. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN);5.5 EXP VERSE UNITIZED SET SCR (PART # 199721001, LOT # WL1231, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.5 E

  Patient problems: No Code Available; Pain

  MAUDE report 10691292 ↗
• InjuryJul 11, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, A REVISION WAS PERFORMED TO REMOVE THE TWO (2) UNKNOWN BROKEN RODS. THE PROCEDURE AND PATIENT CONSEQUENCE WERE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8782866 ↗
• InjuryMay 20, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING SPINAL FUSION, DR. (B)(6) BROUGHT THE PATIENT BACK TO THE OPERATING ROOM FOR A NON-UNION. BOTH RODS BROKE AT L4, WHERE NO SCREWS WERE PLACED FROM THE PREVIOUSLY IMPLANTED CONSTRUCT (T9-ILIUM). THE ORIGINAL T9-ILIUM CONSTRUCT USED EXPEDIUM COCR RODS. WHEN THE REMOVAL OCCURRED, DR. (B)(6) NOTICED THAT THE SCREWS BILATERALLY AT L5, S1 AND L3 ON THE RIGHT. DR. (B)(6) DECIDE TO REMOVE THOSE SCREWS AND REPLACE THEM BY UPSIZING EACH SCREW BY 1MM IN DIAMETER. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HARM/CONSEQUENCE.

  Patient problems: No Code Available

  MAUDE report 8625778 ↗
• InjuryMay 20, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING SPINAL FUSION, DR. (B)(6) BROUGHT THE PATIENT BACK TO THE OPERATING ROOM FOR A NON-UNION. BOTH RODS BROKE AT L4, WHERE NO SCREWS WERE PLACED FROM THE PREVIOUSLY IMPLANTED CONSTRUCT (T9-ILIUM). THE ORIGINAL T9-ILIUM CONSTRUCT USED EXPEDIUM COCR RODS. WHEN THE REMOVAL OCCURRED, DR. (B)(6) NOTICED THAT THE SCREWS BILATERALLY AT L5, S1 AND L3 ON THE RIGHT. DR. (B)(6) DECIDED TO REMOVE THOSE SCREWS AND REPLACE THEM BY UPSIZING EACH SCREW BY 1MM IN DIAMETER. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HARM/CONSEQUENCE.

  Patient problems: No Code Available

  MAUDE report 8625101 ↗
• MalfunctionJan 8, 2019Break; Break

  IT WAS REPORTED PATIENT HAD A SCHEDULED REVISION FOR TWO BROKEN RODS AT L5 AND S1. PATIENT HAD PSEUDOARTHROSIS. DURING REVISION, THE BROKEN RODS WERE REMOVED AND REPLACED. WHILE BENDING THE ROD WITH IN SITU BENDERS, THE NEW ROD BROKE. IT WAS REMOVED AND REPLACED. SURGICAL DELAY OF 10 MINUTES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8228698 ↗
• InjuryJan 8, 2019Break; Break

  IT WAS REPORTED PATIENT HAD A SCHEDULED REVISION FOR TWO BROKEN RODS AT L5 AND S1. PATIENT HAD PSEUDOARTHROSIS. DURING REVISION, THE BROKEN RODS WERE REMOVED AND REPLACED. WHILE BENDING THE ROD WITH IN SITU BENDERS, THE NEW ROD BROKE. IT WAS REMOVED AND REPLACED. SURGICAL DELAY OF 10 MINUTES WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 8228650 ↗
• InjuryJan 8, 2019Break; Break

  IT WAS REPORTED PATIENT HAD A SCHEDULED REVISION FOR TWO BROKEN RODS AT L5 AND S1. PATIENT HAD PSEUDOARTHROSIS. DURING REVISION, THE BROKEN RODS WERE REMOVED AND REPLACED. WHILE BENDING THE ROD WITH IN SITU BENDERS, THE NEW ROD BROKE. IT WAS REMOVED AND REPLACED. SURGICAL DELAY OF 10 MINUTES WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 8228312 ↗
• InjuryNov 15, 2018Break; Break

  IT WAS REPORTED: BROKEN ROD AT L5 LEFT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018). LOOSE PEDICLE SCREW L5 RIGHT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018). BROKEN PEDICLE SCREW S1 RIGHT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018). BROKEN ILIAC SCREW RIGHT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018). LOOSE PEDICLE SCREW L5 LEFT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018). BROKEN EXPEDIUM POLYAXIAL SCREWDRIVER / OCCURRED DURING THE REVISION SURGERY (B)(6) 2018. BROKEN POWER EXPEDIUM / OCCURRED DURING THE REVISION SURGERY (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8074504 ↗
• InjuryJul 13, 2018Break; Break

  IT WAS REPORTED SURGEON COMPLETED A T10-ILIUM POSTERIOR LATERAL FUSION ON (B)(6) 2016 USING THE DEPUY SYNTHES SPINE EXPEDIUM SPINE SYSTEM (5.5MM), VIPER CORTICAL FIX SCREWS, K2M CASCADIA TL INTERBODIES FROM L2-S1, SYNTHES MATRIX SNAP ON TRANSCONNECTOR (AT L4-L5) AND USED VIVIGEN TO AID IN HIS EFFORT TO FUSE. HE PERFORMED THE OPERATION TO CORRECT A SCOLIOSIS. THE PATIENT RETURNED IN (B)(6) 2018 TO SURGEON COMPLAINING OF PAIN. SURGEON OBTAINED A CT AND XRAYS TO EVALUATE THE PATIENT. HE CONFIRMED THAT THE PATIENT HAD FAILED TO FUSE AT L4-L5 AND BROKE THE COCR RODS ON BOTH THE LEFT AND THE RIGHT OF THE LEVELS L4-L5. DUE TO THE FAILED FUSION AND SUBSEQUENT BREAKAGE OF INSTRUMENTATION, SURGEON DECIDED TO TAKE THE PATIENT BACK TO THE OPERATING ROOM TO INSPECT THE CONSTRUCT AND MAKE THE NECESSARY REPLACEMENTS TO STABILIZE THE PATIENT FOR FUSION PURPOSES. SURGEON EXPOSED THE SPINE ON (B)(6) 2018 IN SURGERY AND REMOVED THE COCR RODS (1967-89-300, X2) AS WELL AS THE TRANSCONNECTOR (04.633.347, X1). HE REPLACED SCREWS AT L4, L5, S1 ON THE RIGHT AS WELL AS S1/ILIAC SCREW ON THE LEFT. HE INCREASED THE DIAMETER OF THOSE SCREWS TO GAIN SUFFICIENT SCREW PURCHASE. SURGEON REMOVED THE SCREWS AT T10 A

  Patient problems: Pain; Spinal Column Injury

  MAUDE report 7685037 ↗
• InjuryJul 13, 2018Break; Break

  IT WAS REPORTED SURGEON COMPLETED A T10-ILIUM POSTERIOR LATERAL FUSION ON (B)(6) 2016 USING THE DEPUY SYNTHES SPINE EXPEDIUM SPINE SYSTEM (5.5MM), VIPER CORTICAL FIX SCREWS, K2M CASCADIA TL INTERBODIES FROM L2-S1, SYNTHES MATRIX SNAP ON TRANSCONNECTOR (AT L4-L5) AND USED VIVIGEN TO AID IN HIS EFFORT TO FUSE. HE PERFORMED THE OPERATION TO CORRECT A SCOLIOSIS. THE PATIENT RETURNED IN (B)(6) 2018 TO SURGEON COMPLAINING OF PAIN. SURGEON OBTAINED A CT AND XRAYS TO EVALUATE THE PATIENT. HE CONFIRMED THAT THE PATIENT HAD FAILED TO FUSE AT L4-L5 AND BROKE THE COCR RODS ON BOTH THE LEFT AND THE RIGHT OF THE LEVELS L4-L5. DUE TO THE FAILED FUSION AND SUBSEQUENT BREAKAGE OF INSTRUMENTATION, SURGEON DECIDED TO TAKE THE PATIENT BACK TO THE OPERATING ROOM TO INSPECT THE CONSTRUCT AND MAKE THE NECESSARY REPLACEMENTS TO STABILIZE THE PATIENT FOR FUSION PURPOSES. SURGEON EXPOSED THE SPINE ON (B)(6) 2018 IN SURGERY AND REMOVED THE COCR RODS (1967-89-300, X2) AS WELL AS THE TRANSCONNECTOR (04.633.347, X1). HE REPLACED SCREWS AT L4, L5, S1 ON THE RIGHT AS WELL AS S1/ILIAC SCREW ON THE LEFT. HE INCREASED THE DIAMETER OF THOSE SCREWS TO GAIN SUFFICIENT SCREW PURCHASE. SURGEON REMOVED THE SCREWS AT T10 A

  Patient problems: Pain; Spinal Column Injury

  MAUDE report 7684989 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090648, 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