VIPER 186770145Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705034465791), received between Jul 31, 2018 and Nov 10, 2022 — classified as 9 injuries, 4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN SURGERY WAS PERFORMED WITH THE CORTICAL FIX X-TABS AND THE RODS IN QUESTION. A REVISION PROCEDURE WILL BE PERFORMED FOR FUSION EXTENSION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 45MM. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 15776025 ↗
• InjuryNov 10, 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 ON AN UNKNOWN DATE, AN UNKNOWN SURGERY WAS PERFORMED WITH THE CORTICAL FIX X-TABS AND THE RODS IN QUESTION. A REVISION PROCEDURE WILL BE PERFORMED FOR FUSION EXTENSION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 45MM. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 15775114 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN SURGERY WAS PERFORMED WITH THE CORTICAL FIX X-TABS AND THE RODS IN QUESTION. A REVISION PROCEDURE WILL BE PERFORMED FOR FUSION EXTENSION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 45MM. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 15774812 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN SURGERY WAS PERFORMED WITH THE CORTICAL FIX X-TABS AND THE RODS IN QUESTION. A REVISION PROCEDURE WILL BE PERFORMED FOR FUSION EXTENSION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 45MM. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 15774786 ↗
• InjurySep 20, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS POSTERIOR SPINAL FUSION FOR STENOSIS ON (B)(6) 2022. THE SET SCREW IN QUESTION WAS IDLED WHEN THE TORQUE WAS APPLIED AND TIGHTENED. THE CROSS-THREAD WAS CONFIRMED. THE OPERATION WAS COMPLETED WITH A NEW REPLACEMENT. THEN, THE TAB OF THE SCREW WAS BROKEN IRREGULARLY AT THE 0.5 TO 1 MM PART OF THE CONNECTING PART WHEN THE TAB WAS CUT AS PER SURGICAL TECHNIQUE. THE REMAIN OF THE TAB HAS LEFT IN THE SCREW HEAD. THE SURGEON DETERMINED THAT THERE WAS NO HARM ON THE PATIENT AND REMOVAL WAS IMPOSSIBLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT STATUS: STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)CORTICAL FIX X-TAB 7X45MM TI THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15458973 ↗
• MalfunctionOct 7, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, ON (B)(6) 2020 THE PRIMARY FUSION PROCEDURE (L2-5) WAS PERFORMED. ON AN UNKNOWN DATE THE PATIENT FELL OVER, AND THE SCREWS AT L5 BROKE OFF. THE SURGEON COMMENTED THAT THE EVENT WOULD NOT ADVERSELY AFFECT THE PATIENT¿S HEALTH. SO ANY MEDICAL INTERVENTION IS NOT PLANNED. THIS REPORT IS FOR ONE (1) VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 45MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12589133 ↗
• MalfunctionOct 7, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, ON (B)(6) 2020 THE PRIMARY FUSION PROCEDURE (L2-5) WAS PERFORMED. ON AN UNKNOWN DATE THE PATIENT FELL OVER, AND THE SCREWS AT L5 BROKE OFF. THE SURGEON COMMENTED THAT THE EVENT WOULD NOT ADVERSELY AFFECT THE PATIENT¿S HEALTH. SO ANY MEDICAL INTERVENTION IS NOT PLANNED. THIS REPORT IS FOR ONE (1) VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 45MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12589130 ↗
• MalfunctionAug 16, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6). THE PATIENT UNDERWENT FOR A POSTERIOR FUSION SURGERY. DURING THE SURGERY, THE SCREW WAS BEING INSERTED ON THE L5 RIGHT ROBUST BONE, THE CORE OF THE SCREW GOT STRIPPED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THE PATIENT OUTCOME WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) CORTICAL FIX X-TAB 7X45 MM TI. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12327566 ↗
• InjuryAug 13, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR REVISION PROCEDURE (L3-S) DUE TO SUFFERED FROM ASD AT L3. WHEN THE REVISION PROCEDURE (L3-S) WAS PERFORMED, SCREW LOOSENING WAS REVEALED, WHICH WAS REPLACED WITH A NEW SCREW. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THE PRIMARY OLIF AND TLIF (L3-SAI) WERE PERFORMED ON (B)(6) 2019. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) CORTICAL FIX X-TAB 7X45MM TI. THIS REPORT IS 6 OF 7 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12320331 ↗
• InjuryAug 13, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR REVISION PROCEDURE (L3-S) DUE TO SUFFERED FROM ASD AT L3. WHEN THE REVISION PROCEDURE (L3-S) WAS PERFORMED, SCREW LOOSENING WAS REVEALED, WHICH WAS REPLACED WITH A NEW SCREW. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THE PRIMARY OLIF AND TLIF (L3-SAI) WERE PERFORMED ON (B)(6) 2019. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) CORTICAL FIX X-TAB 7X45MM TI. THIS REPORT IS 7 OF 7 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12320329 ↗
• InjuryJan 22, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT¿S CAGE AT L5/S1 HAD BACKED OUT AND THE SCREW AT S1 HAD BROKEN OFF POST-OP. ON (B)(6) 2019 THE PATIENT UNDERWENT THE PRIMARY MIS-TLIF PROCEDURE AT L5/S WHICH WAS PERFORMED TO TREAT LUMBAR DEGENERATIVE SPONDYLOLISTHESIS. THE PROCEDURE WAS COMPLETED LESS THAN THIRTY (30) MINUTE SURGICAL DELAY. ON (B)(6) 2020 THE PATIENT UNDERWENT THE REVISION PROCEDURE FOR THE BACKED OUT CAGE AND BROKEN SCREW. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF THIRTY (30) MINUTES. CONCOMITANT DEVICE REPORTED: LOCKING/SETSCREWS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN); ROD (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN); T-PAL PROTI, 10X7X28 MM ( PART NUMBER 108812007, LOT 112210, QUANTITY 1). THIS REPORT INVOLVES ONE (1) VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 11214451 ↗
• MalfunctionApr 27, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR A SPINAL FUSION IN THE LUMBAR SPINE TREATING CENTRUM FRACTURE ON (B)(6) 2020. WHEN THE SURGEON TRIED TO PULL THE SCREW BACK AND TURNED A SLEEVE COUNTERCLOCKWISE, WHICH RESULTED IN TAB BREAKAGE. THE SCREW WAS REMOVED, AND A REPLACEMENT WAS USED TO COMPLETE THE REST OF THE PROCEDURE WITHOUT SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10002082 ↗
• InjuryJul 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FURTHER TO (B)(4), ON (B)(6) 2018, WHEN THE PATIENT VISITED THE HOSPITAL DUE TO A LOWER BACK PAIN, THE BREAKAGE OF THE ROD (196789600) WAS FOUND UNDER THE X-RAY BETWEEN L4 AND L5 (RIGHT), AND BETWEEN L5 AND S (LEFT). ON (B)(6) 2018, THE RE-OPERATION WAS RESCHEDULED DUE TO THE PATIENT¿S HIGH CRP (C-REACTIVE PROTEIN) LEVEL. ON (B)(6) 2018, THE RE-OPERATION WAS PERFORMED TO FIND THE CAUSE OF THE PATIENT¿S HIGH CRP (C-REACTIVE PROTEIN) LEVEL, CONSIDERING THE SUSPECTED INFECTIONS. THE PROCEDURES WERE CONDUCTED IN THE FOLLOWING WAY. - SCREWS AT L4, L5 AND S1 (RIGHT) WERE EXTRACTED AND NEW SCREWS WERE INSERTED AT L5 AND S1 TO CONNECT WITH UPPER RODS USING A CONNECTOR. - A SCREW AT L5 (LEFT) WAS EXTRACTED TO CONNECT WITH UPPER RODS USING A CONNECTOR. - SI SET SCREWS AT L4 AND OVER (BOTH SIDES) WERE REPLACED WITH NEW ONES, AND RODS AT FAR END WERE ALSO REPLACED WITH NEW ONES. ALSO, THE FOLLOWING WERE COMMENTED BY THE SURGEON. - LOOSENING OF ALL THE SCREWS WERE OBSERVED WHEN EXTRACTED - TORQUE WAS NOT PROPERLY APPLIED TO SI SET SCREWS WHEN EXTRACTED. - BLACK-COLORED SUBSTANCES WERE SEEN AROUND THE SCREW AND THE ROD, WHICH MIGHT HAVE BEEN CAUSED BY THE METAL CORROSION. - THE PATIENT¿S CRP LEV

  Patient problems: Unspecified Infection

  MAUDE report 7736616 ↗