VIPER 186731745Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10705034352015), received between Jun 29, 2017 and Jan 30, 2024 — classified as 33 injuries, 10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2024Adverse 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 THIS WAS AN ORIGINAL UNKNOWN SURGERY OCCURRED ON (B)(6) 2020. POST-OPERATIVELY ON AN UNKNOWN DATE, ADJACENT SEGMENT DISEASE (ASD) OCCURRED. A REVISION SURGERY OCCURRED TO EXTEND FIXATION AND REMOVE HARDWARE ON (B)(6) 2023. THE SFX CROSS-LINK WAS REMOVED. SET SCREW AND ROD WERE REMOVED. OF THE SCREWS IN L3-5, ONLY L3 AND L4 SCREWS WERE REMOVED. (BONE FUSION WAS COMPLETED) L5 SCREW WERE PRESERVED. S ADDITIONAL SCREW OF 7.0-45MM DIAMETER WAS INSERTED. L5-S TLIF WAS PERFORMED.(CAGE WAS OTHER COMPANY¿S PRODUCT.) SFX CROSS-LINK WAS PLACED, AND THE FINAL TIGHTENING WAS DONE. THIS REPORT IS FOR ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM FOR (B)(4). (B)(4) ARE LINKED. ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED FOR THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 18605337 ↗
• InjuryJan 30, 2024Adverse 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 THIS WAS AN ORIGINAL UNKNOWN SURGERY OCCURRED ON (B)(6) 2020. POST-OPERATIVELY ON AN UNKNOWN DATE, ADJACENT SEGMENT DISEASE (ASD) OCCURRED. A REVISION SURGERY OCCURRED TO EXTEND FIXATION AND REMOVE HARDWARE ON (B)(6) 2023. THE SFX CROSS-LINK WAS REMOVED. SET SCREW AND ROD WERE REMOVED. OF THE SCREWS IN L3-5, ONLY L3 AND L4 SCREWS WERE REMOVED. (BONE FUSION WAS COMPLETED) L5 SCREW WERE PRESERVED. S ADDITIONAL SCREW OF 7.0-45MM DIAMETER WAS INSERTED. L5-S TLIF WAS PERFORMED.(CAGE WAS OTHER COMPANY¿S PRODUCT.) SFX CROSS-LINK WAS PLACED, AND THE FINAL TIGHTENING WAS DONE. THIS REPORT IS FOR ONE EXPEDIUM SPINE SYSTEM SINGLE INNER SET SCREW 5.5 FOR (B)(4). (B)(4) ARE LINKED. ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED FOR THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 18605083 ↗
• InjuryJan 29, 2024Adverse 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 THIS WAS AN ORIGINAL UNKNOWN SURGERY OCCURRED ON (B)(6), 2020. POST-OPERATIVELY ON AN UNKNOWN DATE, ADJACENT SEGMENT DISEASE (ASD) OCCURRED. A REVISION SURGERY OCCURRED TO EXTEND FIXATION AND REMOVE HARDWARE ON (B)(6), 2023. THE SFX CROSS-LINK WAS REMOVED. SET SCREW AND ROD WERE REMOVED. OF THE SCREWS IN L3-5, ONLY L3 AND L4 SCREWS WERE REMOVED. (BONE FUSION WAS COMPLETED) L5 SCREW WERE PRESERVED. S ADDITIONAL SCREW OF 7.0-45MM DIAMETER WAS INSERTED. L5-S TLIF WAS PERFORMED.(CAGE WAS OTHER COMPANY¿S PRODUCT.) SFX CROSS-LINK WAS PLACED, AND THE FINAL TIGHTENING WAS DONE. THIS REPORT IS FOR ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM FOR (B)(4). (B)(4) ARE LINKED. ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED FOR THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 18597023 ↗
• InjuryJan 29, 2024Adverse 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 THIS WAS AN ORIGINAL UNKNOWN SURGERY OCCURRED ON (B)(6) 2020. POST-OPERATIVELY ON AN UNKNOWN DATE, ADJACENT SEGMENT DISEASE (ASD) OCCURRED. A REVISION SURGERY OCCURRED TO EXTEND FIXATION AND REMOVE HARDWARE ON (B)(6) 2023. THE SFX CROSS-LINK WAS REMOVED. SET SCREW AND ROD WERE REMOVED OF THE SCREWS IN L3-5, ONLY L3 AND L4 SCREWS WERE REMOVED. (BONE FUSION WAS COMPLETED) L5 SCREW WERE PRESERVED. ADDITIONAL SCREW OF 7.0-45MM DIAMETER WAS INSERTED. L5-S TLIF WAS PERFORMED.(CAGE WAS OTHER COMPANY¿S PRODUCT.) SFX CROSS-LINK WAS PLACED, AND THE FINAL TIGHTENING WAS DONE. THIS REPORT IS FOR ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM FOR (B)(4). (B)(4) ARE LINKED. ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED FOR THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 18596560 ↗
• InjuryJan 9, 2024Adverse 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 AN UNKNOWN SPINE SURGERY OCCURRED ON (B)(6) 2018. POST OPERATIVELY, THE EXTENDED RE-FUSION SURGERY WILL BE PERFORMED DUE TO THE ADJACENT INTERVERTEBRAL DISORDERS. IT IS CONFIRMED L4/5 ACHIEVED OSTEOSYNTHESIS. THE PLAN IS TLIF FOR L2/3, AND L5 MIGHT BE REMOVED DEPENDING ON INTRAOPERATIVE DECISION. NO FURTHER INFORMATION IS AVAILABLE. (B)(6). THIS REPORT IS FOR ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM FOR (B)(6).

  Patient problems: Osteolysis

  MAUDE report 18475384 ↗
• InjuryJan 9, 2024Adverse 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 AN UNKNOWN SPINE SURGERY OCCURRED ON (B)(6) 2018. POST OPERATIVELY, THE EXTENDED RE-FUSION SURGERY WILL BE PERFORMED DUE TO THE ADJACENT INTERVERTEBRAL DISORDERS. IT IS CONFIRMED L4/5 ACHIEVED OSTEOSYNTHESIS. THE PLAN IS TLIF FOR L2/3, AND L5 MIGHT BE REMOVED DEPENDING ON INTRAOPERATIVE DECISION. NO FURTHER INFORMATION IS AVAILABLE. (B)(4) AND (B)(4) ARE LINKED TO (B)(4). (B)(4) (DEPUY SPINE): SCREWS. (B)(4) (SYNTHES SPINE): CAGES. THIS REPORT IS FOR ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18475272 ↗
• InjurySep 28, 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 A SPINAL SURGERY ON (L3-L5) WAS PERFORMED ON (B)(6), 2017. AFTER SURGERY, ADJACENT SPINE DISEASE (ASD) OCCURRED. ON (B)(6), 2023, A REOPERATION TO EXTEND FIXATION WAS PERFORMED. IN THE REOPERATION, PLIF WAS PERFORMED, EXPEDIUM SCREWS AND OTHER COMPANY¿S (MEDACTA¿S) CAGES WILL BE USED. THIS REPORT IS FOR ONE SINGLE-INNER SETSCREW FOR (B)(4). (B)(4) AND (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED TO CAPTURE THE ADDITIONAL IPS.

  Patient problems: Osteolysis

  MAUDE report 17839804 ↗
• InjurySep 26, 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 AN UNKNOWN SURGERY WAS PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, A REOPERATION VIA POSTERIOR FUSION (L3 ¿ S2) WAS PERFORMED TO EXTEND FIXATION. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES THE RODS INVOLVED IN THIS EVENT. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS A DEVICE MALFUNCTION THAT OCCURRED DURING THE REVISION SURGERY. THIS IS REPORT 7 OF 13 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17818332 ↗
• InjurySep 26, 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 AN UNKNOWN SURGERY WAS PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, A REOPERATION VIA POSTERIOR FUSION (L3 ¿ S2) WAS PERFORMED TO EXTEND FIXATION. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES THE RODS INVOLVED IN THIS EVENT. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS A DEVICE MALFUNCTION THAT OCCURRED DURING THE REVISION SURGERY. THIS IS REPORT 8 OF 13 FOR (B)(4)

  Patient problems: Insufficient Information

  MAUDE report 17818307 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) AND (B)(4) ARE RELATED TO EACH OTHER. PC-001445694 HAS BEEN CREATED TO CAPTURE THE ADDITIONAL IPS.

  Patient problems: Osteolysis

  MAUDE report 17790141 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED TO CAPTURE THE ADDITIONAL IPS.

  Patient problems: Osteolysis

  MAUDE report 17790137 ↗
• MalfunctionJun 27, 2023Difficult to Advance; Compatibility Problem; Difficult to Advance; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON JUNE 7, 2023, A REOPERATION VIA POSTERIOR FUSION (L2 AND L3) WAS PERFORMED. THE SURGEON TRIED TO INSERT THE SCREW (7.0×50) INTO L3, BUT THERE WAS TREMENDOUS STRONG RESISTANCE, AND THE SCREW COULD NOT BE INSERTED FURTHER. THE SURGEON JUDGED TO SHAVE A BURR HOLE AGAIN USING A COMPETITORS INSTRUMENT AND THE SCREW WAS SUCCESSFULLY INSERTED INTO L3. AT THE TIME OF INSERTING THE SCREW INTO L2, THE SCREW WAS NOT INSERTED SMOOTHLY EITHER AND IT WAS REMOVED ONCE. AND THEN, SOMEHOW THE SURGEON FELT UNCOMFORTABLE, SO THE SURGEON CHANGED TO ANOTHER SCREWDRIVER, REPLACED THE SCREW JUST TO BE SURE, AND INSERTED A NEW SCREW INTO L2. DURING THE REOPERATION, A NURSE NOTICED THAT THE STAR SHAPE AT THE TIP OF THE SCREWDRIVER WAS ROUNDED OFF AND DISCOVERED THAT THE TIP OF THE SCREWDRIVER WAS STUCK IN THE CORE OF THE SCREW INSERTED INTO L3. THE METAL STUCK IN THE CORE OF THE SCREW WAS TRIED TO BE REMOVED BUT FAILED. A ROD WAS SET, AND THE SCREW WAS TRIED AGAIN TO BE REMOVED BY TURNING THE SCREW HEAD, BUT THE SCREW WAS INSERTED SO TIGHTLY SO THAT THE SCREW HEAD IDLED. AFTER REPEATING TURNING THE SCREW HEAD, THE META

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17211022 ↗
• InjuryMar 30, 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 THE PATIENT UNDERWENT A SPINAL FUSION (L3/4) ON (B)(6) 2014. AFTER SURGERY, ADJACENT INTERVERTEBRAL DISORDER OCCURRED AT L2/3 AND L4/5. ON (B)(6) 2023, A REOPERATION WAS PERFORMED. IN THE REOPERATION, SET SCREWS AND RODS OF L3/4 WERE REMOVED, AND SCREWS WERE ADDED TO L2 AND L5. TLIF TREATING L2/3 AND TLIF TREATING L4/5 WERE DONE. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THERE IS NO PROBLEM IN THE FUSION SITE TREATED IN THE INITIAL SURGERY IN 2024. THIS REPORT INVOLVES ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 16644052 ↗
• InjuryMar 30, 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 THE PATIENT UNDERWENT A SPINAL FUSION (L3/4) ON (B)(6) 2014. AFTER SURGERY, ADJACENT INTERVERTEBRAL DISORDER OCCURRED AT L2/3 AND L4/5. ON (B)(6) 2023, A REOPERATION WAS PERFORMED. IN THE REOPERATION, SET SCREWS AND RODS OF L3/4 WERE REMOVED, AND SCREWS WERE ADDED TO L2 AND L5. TLIF TREATING L2/3 AND TLIF TREATING L4/5 WERE DONE. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THERE IS NO PROBLEM IN THE FUSION SITE TREATED IN THE INITIAL SURGERY IN 2024. THIS REPORT INVOLVES ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 16644039 ↗
• InjuryDec 30, 2022Adverse 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 THE PATIENT UNDERWENT A PLIF ON (B)(6) 2018. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. ON (B)(6) 2022, AN EXTENSION TO THE UPPER VERTEBRAL BODY REVISION PLIF WAS SCHEDULED TO BE PERFORMED BECAUSE THE PATIENT DEVELOPED AN ADJACENT INTERVERTEBRAL DISORDER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM. THIS IS REPORT 3 OF 12 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 16078287 ↗
• InjuryDec 30, 2022Adverse 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 THE PATIENT UNDERWENT A PLIF ON (B)(6) 2018. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. ON (B)(6) 2022, AN EXTENSION TO THE UPPER VERTEBRAL BODY REVISION PLIF WAS SCHEDULED TO BE PERFORMED BECAUSE THE PATIENT DEVELOPED AN ADJACENT INTERVERTEBRAL DISORDER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM. THIS IS REPORT 4 OF 12 FOR (B)(4)..

  Patient problems: Osteolysis

  MAUDE report 16078285 ↗
• InjuryAug 29, 2022Difficult to Advance; Difficult to Advance

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A REVISION FOR A PLIF PROCEDURES (L3) FOR TREATING ASD. AFTER A SCREW (6.0 MM IN DIAMETER) WAS REMOVED FROM THE LESION, A REPLACEMENT SCREW WAS PREPARED. THE SCREW DID NOT ADVANCE FURTHER AGAINST THE MUCH-HARDENED BONE. WHEN THE SURGEON FORCED THE SCREW WITH THE SCREWDRIVER, ITS TIP BROKE OFF. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Unspecified Tissue Injury

  MAUDE report 15312796 ↗
• MalfunctionAug 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A REVISION PROCEDURE (PLIF AT L5) FOR TREATING DEGENERATIVE DISEASE, AN MSD LEGACY SCREW (55 MM X 45 MM) WAS DEPLOYED FIRMLY IN THE LESION. THE SCREW IN QUESTION (7.0 MM X 45 MM) WAS SELECTED AND INSERTED AS A REPLACEMENT WITH THE HELP OF CT. HOWEVER, THE SCREW WAS NOT ABLE TO BE DEPLOYED AT ALL IN THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER SCREW (8.0 MM X 45 MM) WHICH RESULTED IN LESS THAN 30-MINUTE SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15311024 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A PLIF FOR TREATING SPONDYLOLISTHESIS (IN ONE INTERVERTEBRAL LESION) ON (B)(6) 2022. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUE. HOWEVER, THE PATIENT'S HEART SUDDENLY STOPPED DURING CLOSING INCISION. THEY CAME TO THE FOLLOWING CONCLUSIONS. THERE WAS NO DEFECTIVENESS INVOLVED WITH THE DEVICES. THE HEART STOPPAGE DID NOT BECOME FATAL. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.

  Patient problems: Cardiac Arrest

  MAUDE report 14688968 ↗
• InjuryFeb 16, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL PROCEDURE DUE TO SEVERE PUS IN THE LESION. DURING THE REMOVAL PROCEDURE THE SETSCREW CHIPPED. THE SURGEON REMOVED TWO FRAGMENTS FROM THE PATIENT¿S LESION. NO MORE FRAGMENTS WERE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THE PATIENT RECEIVED THE IMPLANTS ON (B)(6) 2015 AND THE BONE FUSION HAD NOT BEEN ATTAINED AT THE TIME OF THE REMOVAL SURGERY. THIS REPORT INVOLVES ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Purulent Discharge

  MAUDE report 13543489 ↗
• InjuryAug 23, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A SURGERY FOR POSTERIOR SPINAL FUSION IN (B)(6) 2020. AT A FOLLOW UP APPOINTMENT IN (B)(6) 2020, XRAY IMAGES SHOWED THAT THE SET SCREW HAD LOOSENED FROM THE SAI SCREWS BILATERALLY AND THE ROD HAD LOOSENED DUE TO HEAD SPLAY. THE S1 AND L5 SCREWS HAD FRACTURED AT THE NECK OF THE SCREW JUST BELOW THE TULIP. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. THE PATIENT DID NOT ACHIEVE A FUSION BELOW L5 DUE TO THIS HARDWARE FAILURE. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 5.5 TI CORT FIX 7X45MM. THIS REPORT IS 4 OF 5 FOR (B)(4).

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

  MAUDE report 12354209 ↗
• InjuryAug 23, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A SURGERY FOR POSTERIOR SPINAL FUSION IN (B)(6) 2020. AT A FOLLOW UP APPOINTMENT IN (B)(6) 2020, XRAY IMAGES SHOWED THAT THE SET SCREW HAD LOOSENED FROM THE SAI SCREWS BILATERALLY AND THE ROD HAD LOOSENED DUE TO HEAD SPLAY. THE S1 AND L5 SCREWS HAD FRACTURED AT THE NECK OF THE SCREW JUST BELOW THE TULIP. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. THE PATIENT DID NOT ACHIEVE A FUSION BELOW L5 DUE TO THIS HARDWARE FAILURE. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 5.5 TI CORT FIX 7X45MM. THIS REPORT IS 5 OF 5 FOR (B)(4).

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

  MAUDE report 12354178 ↗
• InjuryAug 23, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A SURGERY FOR POSTERIOR SPINAL FUSION IN (B)(6) OF 2020. AT A FOLLOW UP APPOINTMENT IN (B)(6) OF 2020, XRAY IMAGES SHOWED THAT THE SET SCREW HAD LOOSENED FROM THE SAI SCREWS BILATERALLY AND THE ROD HAD LOOSENED DUE TO HEAD SPLAY. THE S1 AND L5 SCREWS HAD FRACTURED AT THE NECK OF THE SCREW JUST BELOW THE TULIP. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. THE PATIENT DID NOT ACHIEVE A FUSION BELOW L5 DUE TO THIS HARDWARE FAILURE. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 5.5 TI CORT FIX 7X45 MM. THIS REPORT IS 1 OF 5 FOR (B)(4).

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

  MAUDE report 12354133 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A REVISION TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY WAS BEING PERFORMED. THE PATIENT ALREADY HAD 4 SCREWS INSIDE; THE SURGEON REMOVED THE 4 SCREWS AND CHOOSE TO RE-INSERT 2 OUT OF THE 4 SCREWS AT L4. IT WAS ONE OF THESE SCREWS THAT ENCOUNTERED THE PROBLEM, AS THE SURGEON WENT TO RE INSERT THE 7.0X45MM CORTICAL FIX VIPER SCREW AT THE L4 PEDICLE, THE TULIP HEAD OF THE SCREW POPPED OFF, LEAVING THE BODY OF THE SCREW SEPARATE FROM THE SCREW HEAD. THE SURGEON WAS ABLE TO REMOVE THE REMAINDER OF THE SCREW AND REPLACED IT WITH A NEW SCREW, CHOOSING TO TAP BEFORE INSERTING THE NEW SCREW. THERE WERE NO ISSUES WITH THE NEW SCREW. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REMOVING THE BROKEN SCREW FROM THE FIELD AND REPLACING THE NEW SCREW. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 5.5 TITANIUM (TI) CORTICAL FIX 7X45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740177 ↗
• MalfunctionJan 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE UPON INSERTION OF A 7.0MM VIPER CORTICAL FIX FENESTRATED SCREW, THE SCREWDRIVER TIP BROKE OFF AND BECAME LODGED WITHIN THE HEAD OF THE BONE SCREW. THE PEDICLE WAS TAPPED PRIOR TO INSERTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 7X45MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197424 ↗