VIPER 186731645Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705034351834), received between Sep 18, 2017 and Feb 26, 2026 — classified as 18 injuries, 5 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 26, 2026Break; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WERE TWO BROKEN SCREWS AT THE S1 LOCATION. THE SCREWS FRACTURED JUST BELOW THE CORTICAL THREADS, AND THE REMAINDER OF THE SCREWS HAD TO BE LEFT IN THE BODY IN THE SACRUM. IT IS REPORTED THAT THE BREAKAGE OCCURRED DURING A REVISION PROCEDURE WHEN THE SURGEON ATTEMPTED TO REMOVE THE SCREWS, HOWEVER IT IS ALSO REPORTED THAT IT IS UNCLEAR WHETHER THE FAILURE HAPPENED DURING REMOVAL, IMPLANTATION, OR THE HEALING PROCESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24457616 ↗
• InjuryFeb 26, 2026Break; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WERE TWO BROKEN SCREWS AT THE S1 LOCATION. THE SCREWS FRACTURED JUST BELOW THE CORTICAL THREADS, AND THE REMAINDER OF THE SCREWS HAD TO BE LEFT IN THE BODY IN THE SACRUM. IT IS REPORTED THAT THE BREAKAGE OCCURRED DURING A REVISION PROCEDURE WHEN THE SURGEON ATTEMPTED TO REMOVE THE SCREWS, HOWEVER IT IS ALSO REPORTED THAT IT IS UNCLEAR WHETHER THE FAILURE HAPPENED DURING REMOVAL, IMPLANTATION, OR THE HEALING PROCESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24457612 ↗
• MalfunctionAug 29, 2025Break; Break

  IT WAS REPORTED A POSTERIOR SPINAL FUSION (LUMBAR) FOR SPINAL CANAL STENOSIS OCCURRED ON (B)(6) 2024, WITH THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2025, THE SALES REP WAS INFORMED BY THE SURGEON THAT THE SCREW HAD BROKEN. CURRENTLY, THE PATIENT HAS NO SYMPTOMS. PATIENT IS STABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923605 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT THIS WAS A POSTERIOR SPINAL FUSION (LUMBAR) FOR SPINAL CANAL STENOSIS ON (B)(6) 2024, WITH THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2025, THE SALES REP WAS INFORMED BY THE SURGEON THAT THE SCREW HAD BROKEN. CURRENTLY, THE PATIENT HAS NO SYMPTOMS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021486 ↗
• 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 THAT THIS WAS AN UNKNOWN SURGERY ON (B)(6), 2018. AFTER THE SURGERY, THE EXTENDED RE-FUSION SURGERY WILL BE PERFORMED DUE TO THE ADJACENT INTERVERTEBRAL DISORDERS. IT IS CONFIRMED L4/5 ACHIEVED OSTEOSYNTHESIS. THE REVISION SURGERY WAS PERFORMED ON (B)(6), 2023. THE SET SCREWS, RODS AND THE CROSSLINKS WERE REMOVED. PLIF WAS PERFORMED ON L1/2, AND TLIF WAS PERFORMED ON L2/3 AND EXTENDED. L1:EXPEDIUM DIAMETER5.0-40×2. L2 LEFT: DIAMETER5.0-45 RIGHT DIAMETER6.0-45. L2/3:CAGECONCORDE H8×W9×L23×ANGLE5. CROSSLINK: A4 ANDA5. L1-L5: ROD CONNECTION. REMARKS: (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (DEPUY SPINE): SCREWS. (B)(4) (SYNTHES SPINE): CAGES. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 6X45MM. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18476667 ↗
• 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 THAT THIS WAS AN UNKNOWN SURGERY ON (B)(6) 2018. AFTER THE SURGERY, THE EXTENDED RE-FUSION SURGERY WILL BE PERFORMED DUE TO THE ADJACENT INTERVERTEBRAL DISORDERS. IT IS CONFIRMED L4/5 ACHIEVED OSTEOSYNTHESIS. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THE SET SCREWS, RODS AND THE CROSSLINKS WERE REMOVED. PLIF WAS PERFORMED ON L1/2, AND TLIF WAS PERFORMED ON L2/3 AND EXTENDED. L1:EXPEDIUM DIAMETER5.0-40×2. L2 LEFT: DIAMETER5.0-45 RIGHT DIAMETER6.0-45. L2/3:CAGECONCORDE H8×W9×L23×ANGLE5. CROSSLINK: A4 ANDA5. L1-L5: ROD CONNECTION. REMARKS: (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (DEPUY SPINE): SCREWS. (B)(4) (SYNTHES SPINE): CAGES. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 6X45MM. THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18476632 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: THE PATIENT HAD A POSTERIOR LUMBAR INTERBODY FUSION (L4/5) PERFORMED ON (B)(6) 2014. AT AN UNKNOWN DATE AFTER THE SURGERY, ASD OCCURRED. IT WAS REPORTED THAT ON (B)(6) 2023, A REVISION PROCEDURE WAS PERFORMED TO EXTEND FIXATION. OLIF WAS PERFORMED IN L2/3 AND L3/4 IN SIDE LYING POSITION. A POSITIONAL CHANGE TO PRONE AND REMOVAL OF EXISTING 4/5 CROSSLINK, SET SCREW AND ROD. PLIF FOR L5/S (USING NON-DEPUY SYNTHES PRODUCT). VERSE SCREW INSERTION AT L2 (DIAMETER 6.0 - LENGTH 45MM), VERSE SCREW INSERTION AT L3 (DIAMETER 7.0 - 45MM). EXPEDIUM-CFS INSERTION IN S1 (DIAMETER 7.0 - LENGTH 40MM), EXPEDIUM-CFS INSERTION IN S2 ALLER (DIAMETER 7.0 - 40MM) OSTEOTOMY, ROD INSTALLATION, SET SCREW, CORRECTION, BONE GRAFT, FINAL TIGHTENING, CROSS-LINK INSTALLATION, THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 6 X 45MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18049946 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: THE PATIENT HAD A POSTERIOR LUMBAR INTERBODY FUSION (L4/5) PERFORMED ON (B)(6) 2014. AT AN UNKNOWN DATE AFTER THE SURGERY, ASD OCCURRED. IT WAS REPORTED THAT ON (B)(6) 2023, A REVISION PROCEDURE WAS PERFORMED TO EXTEND FIXATION. OLIF WAS PERFORMED IN L2/3 AND L3/4 IN SIDE LYING POSITION. A POSITIONAL CHANGE TO PRONE AND REMOVAL OF EXISTING 4/5 CROSSLINK, SET SCREW AND ROD. PLIF FOR L5/S (USING NON-DEPUY SYNTHES PRODUCT) VERSE SCREW INSERTION AT L2 (DIAMETER 6.0 - LENGTH 45MM), VERSE SCREW INSERTION AT L3 (DIAMETER 7.0 - 45MM) EXPEDIUM-CFS INSERTION IN S1 (DIAMETER 7.0 - LENGTH 40MM), EXPEDIUM-CFS INSERTION IN S2 ALLER (DIAMETER 7.0 - 40MM) OSTEOTOMY ROD INSTALLATION SET SCREW CORRECTION BONE GRAFT FINAL TIGHTENING CROSS-LINK INSTALLATION THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 6 X 45MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18049943 ↗
• InjuryJun 26, 2023Device Slipped; Device Slipped

  THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 17204466 ↗
• InjuryJun 1, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A TLIF (L5) FOR SPINAL STENOSIS ON (B)(6) 2015. AFTER SURGERY, AN EXAMINATION ON (B)(6) 2017 REVEALED THE BREAKAGE OF THE 2 SCREWS IN L5. THE CAGE (T-PAL) WAS ALSO FOUND TO BE BACKED OUT ABOUT 10 MM, BUT THE PATIENT WAS UNDER OBSERVATION FOR LACK OF SYMPTOMS. THE PATIENT WAS CURRENTLY SYMPTOM FREE BUT HAD BACK PAIN. ON (B)(6) 2023, A REMOVAL SURGERY WAS PERFORMED AT THE PATIENT'S REQUEST. THE TIPS OF THE BROKEN SCREWS WERE REMAINED IN THE PATIENT¿S BODY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 6X45MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 17043601 ↗
• InjuryJun 1, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A TLIF (L5) FOR SPINAL STENOSIS ON (B)(6) 2015. AFTER SURGERY, AN EXAMINATION ON (B)(6) 2017 REVEALED THE BREAKAGE OF THE 2 SCREWS IN L5. THE CAGE (T-PAL) WAS ALSO FOUND TO BE BACKED OUT ABOUT 10 MM, BUT THE PATIENT WAS UNDER OBSERVATION FOR LACK OF SYMPTOMS. THE PATIENT WAS CURRENTLY SYMPTOM FREE BUT HAD BACK PAIN. ON (B)(6) 2023, A REMOVAL SURGERY WAS PERFORMED AT THE PATIENT'S REQUEST. THE TIPS OF THE BROKEN SCREWS WERE REMAINED IN THE PATIENT¿S BODY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 6X45MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 17043493 ↗
• MalfunctionJul 29, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WAS INSERTING RODS FOR A ¿DRY-FIT¿ BEFORE CEMENT INJECTION AND DISCOVERED THAT THE SADDLE INSIDE OF THE POLY HEAD OF THE SCREW HAD BEEN BROKEN. THIS WOULD NOT ALLOW THE ROD TO SEAT IN THE POLY HEAD AND WOULD ALSO MAKE ATTACHMENT OF THE CEMENT CANNULAS IMPOSSIBLE. THERE WERE NO BROKEN FRAGMENTS. THE SCREW WAS REMOVED WITHOUT ISSUE AND ANOTHER WAS INSERTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCES OR OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 6X45MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15132895 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A PRIMARY POSTERIOR LUMBAR INTERBODY FUSION (PLIF) (L4-5) PROCEDURE. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT HAD SUFFERED FROM ASD BETWEEN L3-4. THE PATIENT WAS SCHEDULED TO UNDERGO A REVISION PROCEDURE (L3-4 PLIF EXTENSION) ON (B)(6) 2021. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 6 X 45MM. THIS IS REPORT 11 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 13177275 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A PRIMARY POSTERIOR LUMBAR INTERBODY FUSION (PLIF) (L4-5) PROCEDURE. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT HAD SUFFERED FROM ASD BETWEEN L3-4. THE PATIENT WAS SCHEDULED TO UNDERGO A REVISION PROCEDURE (L3-4 PLIF EXTENSION) ON (B)(6) 2021. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 6 X 45MM. THIS IS REPORT 10 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 13177274 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A PRIMARY POSTERIOR LUMBAR INTERBODY FUSION (PLIF) (L4-5) PROCEDURE. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT HAD SUFFERED FROM ASD BETWEEN L3-4. THE PATIENT WAS SCHEDULED TO UNDERGO A REVISION PROCEDURE (L3-4 PLIF EXTENSION) ON (B)(6) 2021. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 6 X 45MM. THIS IS REPORT 9 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 13177248 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A PRIMARY POSTERIOR LUMBAR INTERBODY FUSION (PLIF) (L4-5) PROCEDURE. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT HAD SUFFERED FROM ASD BETWEEN L3-4. THE PATIENT WAS SCHEDULED TO UNDERGO A REVISION PROCEDURE (L3-4 PLIF EXTENSION) ON (B)(6) 2021. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 6 X 45MM. THIS IS REPORT 6 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 13177233 ↗
• MalfunctionFeb 15, 2019Break; Break

  AFTER THE EXTENDED SURGERY REPORTED IN (B)(4), ON UNKNOWN DATE OF (B)(6) 2019, THE SURGEON RECOGNIZED THAT THE ROD WAS COME OFF FROM S1 LEFT UNDER X-RAY, AND IT CAUSED PROXIMAL JUNCTIONAL KYPHOSIS. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO REMOVE S1 SCREW BY USING T20 DRIVER (P/N:279702050), AND ONLY SCREW HEAD OF P/N: 186731645 COULD BE REMOVED. THE S1 SET SCREWS WERE NOT LOOSENED BUT DETACHED THE SCREW HEAD FROM THE SHAFT. THE SURGEON REMOVED TWO OF S1 SCREW HEADS FROM THE PATIENT¿S BODY. THE REVISION SURGERY WAS COMPLETED BY IMPLANTING ANOTHER MANUFACTURER¿S SCREWS (MANUFACTURER AND P/N WERE UNKNOWN), AND EXTENDING THE FIXED LOCATION TO TH10~S2AI. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8345053 ↗
• InjuryFeb 14, 2019Disconnection; Disconnection

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2017 BY IMPLANTING THE SCREW (P/N: 186731645) AND SET SCREW (P/N:179702000) TO S1 (ORIGINAL FIXED LOCATION WAS UNKNOWN BUT INCLUDING S1). AFTER THE PRIMARY SURGERY, THE EXTENSION SURGERY WAS PERFORMED ON (B)(6) 2018 TO EXTEND THE FIXED POSITION TO L2-S1 AND REPLACED SET SCREWS (P/N:179702000). NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 8339626 ↗
• InjuryMay 1, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED SURGEON WAS REVISING AN L3-4 NON-UNION WHERE VIPER CORTICAL FIXATION AND A CONCORDE LIFT TLIF CAGE WERE PREVIOUSLY IMPLANTED. WHEN THE SURGEON WENT TO CHECK SCREW BITE HE NOTICED THE HEAD WAS COMPLETELY DETACHED FROM THE SHANK OF THE SCREW. REMAINING 3 SCREWS WERE MODERATELY LOOSE. WE IMPLANTED NEW SCREWS FROM L3-S1.

  Patient problems: Spinal Column Injury

  MAUDE report 7476891 ↗
• InjuryMay 1, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED SURGEON WAS REVISING AN L3-4 NON-UNION WHERE VIPER CORTICAL FIXATION AND A CONCORDE LIFT TLIF CAGE WERE PREVIOUSLY IMPLANTED. WHEN THE SURGEON WENT TO CHECK SCREW BITE HE NOTICED THE HEAD WAS COMPLETELY DETACHED FROM THE SHANK OF THE SCREW. REMAINING 3 SCREWS WERE MODERATELY LOOSE. WE IMPLANTED NEW SCREWS FROM L3-S1.

  Patient problems: Spinal Column Injury

  MAUDE report 7476858 ↗
• InjuryMay 1, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED SURGEON WAS REVISING AN L3-4 NON-UNION WHERE VIPER CORTICAL FIXATION AND A CONCORDE LIFT TLIF CAGE WERE PREVIOUSLY IMPLANTED. WHEN THE SURGEON WENT TO CHECK SCREW BITE HE NOTICED THE HEAD WAS COMPLETELY DETACHED FROM THE SHANK OF THE SCREW. REMAINING 3 SCREWS WERE MODERATELY LOOSE. WE IMPLANTED NEW SCREWS FROM L3-S1.

  Patient problems: Spinal Column Injury

  MAUDE report 7476827 ↗
• InjuryMay 1, 2018Break; Break

  IT WAS REPORTED SURGEON WAS REVISING AN L3-4 NON-UNION WHERE VIPER CORTICAL FIXATION AND A CONCORDE LIFT TLIF CAGE WERE PREVIOUSLY IMPLANTED. WHEN THE SURGEON WENT TO CHECK SCREW BITE HE NOTICED THE HEAD WAS COMPLETELY DETACHED FROM THE SHANK OF THE SCREW. REMAINING 3 SCREWS WERE MODERATELY LOOSE. WE IMPLANTED NEW SCREWS FROM L3-S1.

  Patient problems: Spinal Column Injury

  MAUDE report 7476782 ↗
• MalfunctionSep 18, 2017Break; Break

  ON (B)(6) 2017, REMOVAL SURGERY WAS PERFORMED AT THE FIXED AREA OF L3 ¿ L4. DURING THE SURGERY, AT THE TIME OF REMOVING THE SCREW (PART#: 186731645, LOT#: ATMDNR), THE SCREW GOT BROKEN. THE REMOVAL SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FROM THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6871629 ↗