VIPER 186727745Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705034282671), received between Oct 1, 2018 and Apr 8, 2026 — classified as 13 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT A SCREW WOULDN´T COME LOOSE FROM THE SCREWDRIVER, RESULTING IN THE NEED TO USE A NEW SCREW AND SCREWDRIVER. THERE WAS A 5 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24819470 ↗
• MalfunctionAug 9, 2024Device Slipped; Device Slipped

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS A 20-MINUTE SURGICAL DELAY. THERE WERE NO REPORTS OF PATIENT HARM AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 19955862 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: FRACTURE VERTEBRAL STRUCTURES, WOUND HEALING PROBLEM. COMPLICATION TIME/INTERVENTION. INTRAOPERATIVE, REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE CONFIDENCE SPINAL CEMENT SYSTEM, VIPER /OTHER, VIPER CFX FENESTRATED AND VIPER INSTRUMENTS PRODUCTS. THIS IS REPORT 2 OF 6 FOR COMPLAINT: (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 18464028 ↗
• InjuryJan 8, 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: ADJACENT SEGMENT PATHOLOGY. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VIPER /OTHER AND VIPER CFX FENESTRATED PRODUCTS (MIS TI CFX FEN POLY 7X45 (B)(6).

  Patient problems: Osteolysis

  MAUDE report 18463643 ↗
• InjuryJan 8, 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, POSTOPERATIVE INFECTION DEEP, POSTOPERATIVE INFECTION SUPERFICIAL, COMPLICATION TIME/INTERVENTION, POSTOPERATIVE (BEFORE DISCHARGE), REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VIPER /OTHER AND VIPER CFX FENESTRATED PRODUCTS (MIS TI CFX FEN POLY 7X45 (B)(4)).

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 18463292 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: WOUND INFECTION DEEP, OTHER. COMPLICATION TIME/INTERVENTION. POSTOPERATIVE (BEFORE DISCHARGE), REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 45MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information; Post Operative Wound Infection

  MAUDE report 18453567 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: WOUND INFECTION DEEP, WOUND HEALING PROBLEM. COMPLICATION TIME/INTERVENTION POSTOPERATIVE (BEFORE DISCHARGE), REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE VIPER /OTHER AND VIPER CFX FENESTRATED PRODUCTS THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing; Post Operative Wound Infection

  MAUDE report 18450197 ↗
• InjuryJul 28, 2023Break; Device Slipped; Break; Device Slipped

  1ST/2ND (B)(6) 2022 (IMPLANTATION OF THE CFX/ILIUM SCREWS. A LOOSE SCREWDRIVER ATTACHMENT THAT REMAINED IN THE S1 SCREW DURING THE PROCEDURE ON (B)(6) 2022. FOR REVISION, PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NON-UNION AT L5/S1 WAS REPORTED. NO FRAGMENTS WERE LEFT BEHIND IN THE PATIENT DUE TO BROKEN SCREWS. INTERVENTION WAS REQUIRED TO REMOVE ALL FRAGMENTS. PATIENT STATUS WAS NOTED AS A DECREASE OF PAIN MEDICATION AND A DISCHARGE TO CONTEMPORARY NURSERY HOME NO FURTHER FOLLOW UP. FOR THIS COMPLAINT WE WILL BE REPORTING THE POST-OPERATIVE AND INTRA-OPERATIVE EVENT ON (B)(6). THE REPORTED SCREWS HAD MALFUNCTIONS DURING POST-OPERATIVE AND INTRA-OPERATIVE PHASES OF CARE.

  Patient problems: Insufficient Information

  MAUDE report 17412411 ↗
• InjuryJul 28, 2023Break; Device Slipped; Break; Device Slipped

  ON (B)(6) 2022 (IMPLANTATION OF THE CFX/ILIUM SCREWS. A LOOSE SCREWDRIVER ATTACHMENT THAT REMAINED IN THE S1 SCREW DURING THE PROCEDURE ON (B)(6) 2022. FOR REVISION, PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NON-UNION AT L5/S1 WAS REPORTED. NO FRAGMENTS WERE LEFT BEHIND IN THE PATIENT DUE TO BROKEN SCREWS. INTERVENTION WAS REQUIRED TO REMOVE ALL FRAGMENTS. PATIENT STATUS WAS NOTED AS A DECREASE OF PAIN MEDICATION AND A DISCHARGE TO CONTEMPORARY NURSERY HOME NO FURTHER FOLLOW UP FOR THIS COMPLAINT WE WILL BE REPORTING THE POST-OPERATIVE AND INTRA-OPERATIVE EVENT ON (B)(4) . THE REPORTED SCREWS HAD MALFUNCTIONS DURING POST-OPERATIVE AND INTRA-OPERATIVE PHASES OF CARE.

  Patient problems: Insufficient Information

  MAUDE report 17412410 ↗
• InjuryJul 28, 2023Break; Device Slipped; Break; Device Slipped

  (B)(6) 2022 (IMPLANTATION OF THE CFX/ILIUM SCREWS. A LOOSE SCREWDRIVER ATTACHMENT THAT REMAINED IN THE S1 SCREW DURING THE PROCEDURE ON (B)(6), 2022. FOR REVISION, PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NON-UNION AT L5/S1 WAS REPORTED. NO FRAGMENTS WERE LEFT BEHIND IN THE PATIENT DUE TO BROKEN SCREWS. INTERVENTION WAS REQUIRED TO REMOVE ALL FRAGMENTS. PATIENT STATUS WAS NOTED AS A DECREASE OF PAIN MEDICATION AND A DISCHARGE TO CONTEMPORARY NURSERY HOME NO FURTHER FOLLOW UP FOR THIS COMPLAINT WE WILL BE REPORTING THE POST-OPERATIVE AND INTRA-OPERATIVE EVENT ON (B)(4). THE REPORTED SCREWS HAD MALFUNCTIONS DURING POST-OPERATIVE AND INTRA-OPERATIVE PHASES OF CARE.

  Patient problems: Insufficient Information

  MAUDE report 17412409 ↗
• InjuryJul 28, 2023Break; Break

  1ST/2ND: (B)(6) 2022, IMPLANTATION OF THE CFX/ILIUM SCREWS. A LOOSE SCREWDRIVER ATTACHMENT THAT REMAINED IN THE S1 SCREW, DURING THE PROCEDURE ON (B)(6) 2022. FOR REVISION, PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NON-UNION AT L5/S1 WAS REPORTED. NO FRAGMENTS WERE LEFT BEHIND IN THE PATIENT, DUE TO BROKEN SCREWS. INTERVENTION WAS REQUIRED TO REMOVE ALL FRAGMENTS. PATIENT STATUS WAS NOTED, AS A DECREASE OF PAIN MEDICATION. AND A DISCHARGE TO CONTEMPORARY NURSERY HOME. NO FURTHER FOLLOW UP FOR THIS COMPLAINT, WE WILL BE REPORTING THE POST-OPERATIVE AND INTRA-OPERATIVE EVENT ON (B)(4). THE REPORTED, SCREWS HAD MALFUNCTIONS, DURING POST-OPERATIVE AND INTRA-OPERATIVE PHASES OF CARE.

  Patient problems: Insufficient Information

  MAUDE report 17412406 ↗
• MalfunctionJul 10, 2023Device Slipped; Device Slipped

  THE OPERATION, WAS A SPINOPELVIC STABILIZATION PROCEDURE WITH CFX SCREWS. AFTER INSERTING THE ROD INTO THE SCREW HEADS, THE SURGEON ATTEMPTED TO FIX IT WITH SET SCREWS. AND THE MONO-INNIE TIGHTENED WITHOUT PROBLEMS. HOWEVER, WHEN RE-TIGHTENING WITH THE TORQUE LIMITER, THE INNIE OVERTIGHTENED, LEAVING IT LOOSE AGAIN. THE SURGEON CHANGED TO THE ILIUM SCREW, BECAUSE THE SCREW HEAD WAS NO LONGER STABLE. IT WAS RE-ATTEMPTED WITH A NEW CFX SCREW, BUT THE SAME RESULT OCCURRED. THE PROCEDURE WAS ABLE TO BE COMPLETED USING AN EXPEDIUM POLYAXIAL SCREW WITH A DOUBLE INNIE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286743 ↗
• InjuryJun 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022 TWO (2) OUT OF FOUR (4) SCREWS COULD NOT BE REMOVED AND HAD TO BE DRILLED LABORIOUSLY. IT WAS NOT POSSIBLE TO FIT THE SCREWDRIVER INTO THOSE TWO SCREWS. THERE WAS ABOUT NINETY (90) MINUTES OF SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 7X45 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 14641349 ↗
• InjuryJun 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022 TWO (2) OUT OF FOUR (4) SCREWS COULD NOT BE REMOVED AND HAD TO BE DRILLED LABORIOUSLY. IT WAS NOT POSSIBLE TO FIT THE SCREWDRIVER INTO THOSE TWO SCREWS. THERE WAS ABOUT NINETY (90) MINUTES OF SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 7X45. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 14641348 ↗
• MalfunctionDec 28, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, AN OSTEOPOROTIC PATIENT UNDERWENT FOR CEMENT AUGMENTATION. THIS WAS AN MIS PROCEDURE AND VCFFS SCREWS USED. DURING SCREW INSERTION, 2-SCREW HEAD BRAKED AND COME OUT ON ALIGNMENT SLEEVE, WHEREAS SCREW SHANK WAS IN THE VERTEBRAL BODY ITSELF. THERE WAS ISSUE IN INNIE (LOCKING CAP) INSERTION INITIALLY AND INNIES THREADS WERE NOT ENGAGING TO THE SCREW, AND WHEN SURGEON TRIED TO REVISE THE SCREW, BOTH THE HEADS ONLY CAME OUT. TOTAL 2 SCREWS AND 4 INNIES DAMAGED. WITHOUT REMOVING FRAGMENTS, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 60-MINUTES DELAY. THE PATIENT CONSEQUENCES WERE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES (6) DEVICES. THIS REPORT IS FOR (1) MIS TI CFX FEN POLY 7X45. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13100986 ↗
• InjuryAug 31, 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 AN UNKNOWN DATE, AFTER A DORSAL EXTENSION WITH FUSION L4/5 THE PATIENT COMPLAINT ABOUT PERSISTENT LUMBAR PAIN. A CT SCAN-MORPHOLOGICAL SHOWED SCREW LOOSENING BILATERALLY. DURING THE CORRECTIVE PROCEDURE, THE REMOVAL OF THE SCREW S1 ON THE RIGHT, WAS ONLY PARTIALLY REMOVED BECAUSE THE SCREW BROKE DISTALLY IN THE AREA OF THE PERFORATION. A NEW SCREW WAS IMPLANTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12391820 ↗
• MalfunctionAug 17, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING ROBOT-ASSISTED LUMBAR FUSION AND INTERNAL FIXATION ON (B)(6) 2021, THE SCREW BROKE WHILE BEING INSERTED. ANOTHER SCREW WAS USED, BUT THE SAME PROBLEM OCCURRED. A THIRD DEVICE WAS USED TO COMPLETE THE SURGERY. ALL PIECES WERE REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT IS FOR A MIS TI CFX FEN POLY 7X45. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331450 ↗
• MalfunctionAug 17, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING ROBOT-ASSISTED LUMBAR FUSION AND INTERNAL FIXATION ON (B)(6) 2021, THE SCREW BROKE WHILE BEING INSERTED. ANOTHER SCREW WAS USED, BUT THE SAME PROBLEM OCCURRED. A THIRD DEVICE WAS USED TO COMPLETE THE SURGERY. ALL PIECES WERE REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT IS FOR A MIS TI CFX FEN POLY 7X45. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331328 ↗
• MalfunctionJun 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE SCREW HEAD DISENGAGED FROM THE SCREW SHAFT WHILE INSERTING THE SCREW. THERE WAS NO EXTRA FORCE USED. CONCOMITANT DEVICE: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CORTICAL FIX FENESTRATED, 7.0 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106033 ↗
• MalfunctionMay 21, 2019Break; Break

  IT WAS REPORTED THAT THE SCREW FRACTURED JUST BELOW THE TULIP AT THE RIGHT SIDED S1 SCREW. IMPORTANT TO KEEP IN MIND THE PATIENT HAD A SACRALIZED L5. THE SURGEONS ASSISTANT WAS TRYING TO REENGAGE THE VIPER CANNULATED DRIVER, ALONG WITH THE T20, AND THE VIPER 3D THREADED DRIVER SO THAT THEY COULD ADVANCE THE SCREW. THE T20 & VIPER 3D THGD DRIVER BOTH STRIPPED IN THE PROCESS, FOLLOWED BY THE SCREW BREAKING JUST BELOW THE TULIP. THE SURGEON WAS ABLE TO USE UNIVERSAL REMOVAL TO TAKE THE BROKEN PIECE OUT. NOTE THAT WE CONTINUED TO HAVE A PROBLEM WITH EXTENSIONS AT THAT SAME SPOT, THEY KEPT DISENGAGING. THERE WAS NOTHING WRONG WITH THE EXTENSIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8627838 ↗
• MalfunctionApr 26, 2019Break; Break

  THE FOLLOWING WAS REPORTED: SCREW BREAKAGE. IT WAS REPORTED THAT DURING THE POSTERIOR LUMBAR CLOSED REPOSITION AND INTERNAL FIXATION + VERTEBRAL AUGMENTATION, WHEN DID SUBCUTANEOUS ROD INSERTION, THE SCREW EXTENDER ALONG WITH THE SCREW HEAD FELL OFF, USED THE SCREW REMOVAL TOOL TO RETRIEVE THE SCREW ROD, IT WAS NOTED THAT THE CONNECTING RING BETWEEN THE SCREW HEAD AND THE SCREW ROD WAS BROKEN OFF AS THE PHOTO SHOWS. THE SURGERY DELAYED ABOUT 30 MINUTES. THE PATIENT IS STABLE AND IN HOSPITAL NOW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8556899 ↗
• 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 8074698 ↗
• MalfunctionOct 1, 2018Disconnection; Disconnection

  IT WAS REPORTED AN L3-S1 MIS TLIF + POSTERIOR INSTRUMENTED FUSION: (B)(6); (B)(6) HOSPITAL (B)(6) 2018. WHILST TRYING TO SEAT THE ROD, SURGEON WAS UNABLE TO REDUCE SET SCREW INTO HEAD OF TULIP. TRIED MULTIPLE TIMES. SURGEON REQUESTED X-RAY. ON X-RAY IT WAS APPARENT THAT THE TULIP HAD DISENGAGED FROM SHANK OF SCREW. SURGEON WAS ABLE TO RELEASE TULIP FROM EXTENSION TUBE. SHANK OF SCREW WAS BACKED OUT BY T20 DRIVER IN EXPEDIUM KIT. THIS TOOK 2 HOURS, ADDITIONAL TIME FOR PATIENT UNDER ANAESTHESIA. SURGEON WOULD LIKE DEVICE REPORT AS TO THIS LOT NUMBER TO MINIMISE RISK TO OTHER PATIENTS. NOT A DESIRABLE OUTCOME FOR HIS PATIENT.

  Patient problems: Not Applicable

  MAUDE report 7922423 ↗