VIPER 186770140Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034465784), received between Jul 31, 2018 and Aug 30, 2023 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A FUSION OF L4-S1 WAS PERFORMED USING FOUR SCREWS FOR A FRACTURE OF L5. AFTER THE SURGERY, ON (B)(6) 2023, A REMOVAL SURGERY FOR EXTERNAL INJURY WAS PERFORMED. DURING THE REMOVAL SURGERY, THE SURGEON NOTICED THAT THE SCREW INSERTED INTO S1 RIGHT WAS BROKEN OFF. BECAUSE THE BREAKAGE OF THE SCREW OCCURRED AT A DEEP SITE (APPROXIMATELY 3 CM FROM THE SCREW TIP), REMOVAL OF THE BROKEN PORTION OF THE SCREW WAS JUDGED TO BE DIFFICULT TO REMOVE, AND THE WOUND WAS CLOSED. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SURGEON REVIEWED HISTORICAL IMAGING DATA AND FOUND THAT THE SCREW MAY HAVE BROKEN OFF AROUND (B)(6) 2023. X-RAYS CONFIRMED THAT THERE WERE NO DAMAGED FRAGMENTS IN THE BODY EXCEPT FOR THE REMAINING PORTION OF THE BROKEN SCREW. THIS REPORT INVOLVES ONE VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17649935 ↗
• 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 7X40MM TI THIS REPORT IS 5 OF 7 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12320416 ↗
• 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 7X40MM TI. THIS REPORT IS 2 OF 7 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12319691 ↗
• 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 7X40MM TI. THIS REPORT IS 4 OF 7 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12319622 ↗
• InjuryJan 26, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L4/L5, FOR THE TREATMENT OF SPONDYLOLISTHESIS, AFTER THE SURGEON PLACED THE RODS, THE SCREW BROKE OFF. THE SURGEON CONFIRMED THAT FRAGMENTED BURR ON THE BROKEN SCREW WAS ONE (1) MM ABOVE THE TOP OF THE SETSCREWS AND DECIDED TO LEAVE THE SCREW IN THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED WITH A LESS THAN THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER THE PROCEDURE. CONCOMITANT DEVICES REPORTED: SCREWDRIVER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN); RODS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN); SETSCREWS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11229728 ↗
• MalfunctionJan 3, 2020Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT A PLIF (POSTERIOR LUMBAR INTERBODY FUSION) FOR L2-5 TREATING LSCS (LUMBAR SPINAL CANAL STENOSIS) ON (B)(6) 2019. WHEN COMPRESSION WAS APPLIED TO THE SCREW, IT MOVED LATERALLY, AND THE COMPRESSION FAILED. REPLACING A SETSCREW DID NOT CORRECT THE ISSUE. FINALLY, THE SURGEON COMPLETED THE PROCEDURE WITH A REPLACING SCREW WITH LESS THAN THIRTY (30) MINUTES SURGICAL DELAY. IT WAS POSTOPERATIVELY KNOWN THAT ANOTHER SURGEON WAS NOT ABLE TO APPLY A NON-J&J PROBE TO THE TARGETED LESION PRIOR TO THE SCREW¿S INSERTION. WHEN THE PROBE HAPPENED TO BE APPLIED LATERALLY OFF THE TARGETED AREA, THE PEDICLE BONE BROKE/FRACTURED. THEY CONCLUDED THAT THE COMPRESSION THROUGH THE SCREW FAILED DUE TO SUCH A PROBE APPLICATION. THE SURGEON POSTOPERATIVELY CONFIRMED THAT THE VIPER COMPRESSOR COULD APPLY COMPRESSION APPROPRIATELY. THIS REPORT IS FOR A TITANIUM (TI) MIS CANNULATED CORTICAL FIX X-TAB 7X40MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9545007 ↗
• InjuryOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 VIA POSTERIOR SPINE FUSION TO FIX TH11-L2 BY USING HA BLOCK (MANUFACTURER WAS PENTAX, P/N AND LOT NUMBER WERE UNKNOWN), SCREWS TO TH11, 12, L1 AND L2, AND SET SCREWS. AFTER THE PRIMARY SURGERY ON UNKNOWN DATE, THE SURGEON RECOGNIZED THAT THE PATIENT SUFFERED THE INFECTION. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2018 TO REMOVE THE RODS, SET SCREWS, AND THE SCREWS AT TH12 AND L1,AND THE IMPLANTED THE NEW SCREWS (P/N AND LOT NUMBER WERE UNKNOWN) TO TH10 AND L3, AND THEN FIX WITH NEW RODS (P/N AND LOT NUMBER WERE UNKNOWN) AT TH10.11.L2.3 USING NEW SET SCREWS (P/N AND LOT NUMBER WERE UNKNOWN). NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8025575 ↗
• 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 LEVEL MIGHT HAVE

  Patient problems: Unspecified Infection

  MAUDE report 7737485 ↗
• 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 LEVEL MIGHT HAVE

  Patient problems: Unspecified Infection

  MAUDE report 7736478 ↗