VIPER 186731740Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705034352008), received between Apr 9, 2018 and Jan 9, 2024 — classified as 17 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 7X40MM. THIS IS REPORT 10 OF 10 FOR COMPLAINT: (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18476649 ↗
• 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) 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 40MM FOR (B)(4). THIS REPORT IS FOR ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 40MM FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18475062 ↗
• MalfunctionNov 8, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN TAIWAN AS FOLLOWS: IT WAS REPORTED (B)(6) 2023, THAT THE HEAD FELL OFF HALFWAY THROUGH THE LOCK, AND THE SLEEVE HELD THE NAIL HEAD AND FELL OFF (THE SLEEVE IS STILL MOVING). CHANGE NEW PRODUCT. YES, THERE WAS PATIENT INVOLVEMENT. THE OPERATION WENT WELL, NO ADVERSE REACTION. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 7X40MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18095036 ↗
• 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 40MM. 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 1 OF 13 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17818363 ↗
• 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 40MM. 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 2 OF 13 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17818347 ↗
• 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. (B)(4) HAS BEEN CREATED TO CAPTURE THE ADDITIONAL IPS.

  Patient problems: Osteolysis

  MAUDE report 17790133 ↗
• 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 17790132 ↗
• 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 17790131 ↗
• 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 40MM. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 16644042 ↗
• 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 40MM. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 16644033 ↗
• InjurySep 12, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PLIF PROCEDURES (L4/5) FOR TREATING ASD ON (B)(6) 2022. THE EVENT TOOK PLACE IN SEQUENCE AS FOLLOWS: THERE WAS A POSSIBILITY THAT THE SCREW 7.0×40 (UNK), THAT INSERTED TO L5 IN THIS SURGERY WAS LOOSE, SO IT WAS REMOVED. THE SURGEON TRIED TO REPLACE IT WITH THE SCREW 8.0×40 AND TRIED TO INSERT IT BUT WAS UNABLE TO INSERT IT DUE TO RESISTANCE. THE TIP OF THE SCREWDRIVER IN QUESTION WAS BROKEN. THE TIP OF THE SCREWDRIVER GOT CAUGHT IN THE CORE OF THE SCREW 8.0×40, AND THE SURGEON HAD DIFFICULTY REMOVING THE SCREW 8.0×40, BUT HE MANAGED TO DO SO AND THE REMOVAL WAS COMPLETED. THE SURGEON COMMENTED THAT THE REASON FOR THE DIFFICULTY IN INSERTING THE SCREW 8.0×40¿WAS THAT THE PATIENT'S BONE WAS QUITE HARD, AND THAT WHEN HE DID NOT TAP THE SCREW 8.0×40 TO BREAK THROUGH ALTHOUGH HE FELT RESISTANCE DURING INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 7X40MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401513 ↗
• MalfunctionAug 19, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT WAS X-RAYED AFTER SCREW INSERTION. IT WAS CONFIRMED THAT THE SCREW IN QUESTION HAD COME OFF THE LESION. WHEN THEY TRIED TO RETRACT THE SCREW WITH THE DRIVER SHAFT, THE TIP OF THE DRIVER SHAFT BROKE OFF. A FRAGMENT WHICH HAD STUCK TO THE SCREW WAS REMOVED FROM THE LESION. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. THE PATIENT¿S BONE WAS QUITE HARD, SO THE SURGEON HAD DIFFICULTY IN THE SCREW INSERTION. PATIENT STATUS/ OUTCOME: THE PATIENT WAS X-RAYED, AND IT WAS CONFIRMED THAT NO FRAGMENT HAD BEEN LEFT IN THE LESION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)5.5 TI CORT FIX 7X40MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15262386 ↗
• MalfunctionJul 22, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PLIF (L4-5) FOR TREATING SPONDYLOLISTHESIS ON (B)(6) 2022 THE 7.0X 40MM SCREW (UNK) CUT OUT DURING SCREW TIGHTENING (WIPER MOTION) WITH THE TORQUE WRENCH IN QUESTION. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT (7.0X 45MM SCREW) LESS THAN 30-MINUTE SURGICAL DELAY. HE COMMENTED THAT THE EVENT MIGHT HAVE BEEN TRIGGERED BY MALFUNCTIONING TORQUE-VALUE SETTING ON THE TORQUE WRENCH. IT WAS BECAUSE AN EXCESSIVE LOAD HAD BEEN UNEXPECTEDLY PUT ONTO THE SCREW. WHEN THE SURGEON WAS APPLYING THE REPLACEMENT, HE ALSO FELT STRONG LOAD EVEN BEFORE TORQUE CAME INTO ACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 7X40MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085949 ↗
• InjuryFeb 23, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT REVISION SURGERY DUE TO TWO BROKEN EXPEDIUM CORTICAL SCREWS AT THE S1 LEVEL. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. PATIENT HAD A PREVIOUS L3-S1 FUSION, WHICH WAS EXTENDED UP TO L2 AND ADDED SAI AFTER REPLACEMENT OF THE BROKEN SCREWS. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR AN UNKNOWN EXPEDIUM SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 13584861 ↗
• InjuryFeb 23, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT REVISION SURGERY DUE TO TWO BROKEN EXPEDIUM CORTICAL SCREWS AT THE S1 LEVEL. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. PATIENT HAD A PREVIOUS L3-S1 FUSION, WHICH WAS EXTENDED UP TO L2 AND ADDED SAI AFTER REPLACEMENT OF THE BROKEN SCREWS. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR AN UNKNOWN EXPEDIUM SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 13584849 ↗
• 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 40MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

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

  MAUDE report 13543387 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, PROCEDURE WAS REVISED DUE TO BACK PAIN AND CONNECTION DEGENERATION. THIS REPORT IS FOR (1) 5.5 TI CORT FIX 7X40MM. THIS IS REPORT 5 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis; Pain

  MAUDE report 12961911 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD POSTERIOR SPINAL FUSION SURGERY DONE ON (B)(6) 2021. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 AS THE PATIENT WAS HAVING COMPLICATION FROM A RIGHT SIDE S1 PEDICLE SCREW. THE PATIENT WAS EXPERIENCING RIGHT SIDE LEG PAIN. THE SCREW WAS REMOVED AND NEW IMPLANTS WERE PUT IN. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 40MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12378820 ↗
• MalfunctionJul 28, 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) 2021, THE PATIENT UNDERWENT FOR A PLIF AT L5 TREATING SPINAL CANAL STENOSIS. DURING THE SURGERY, THE SCREWDRIVER WAS NOT ABLE TO BE ATTACHED TO THE SCREW. SOME DEFORMITY WAS FOUND INSIDE THE SCREWHEAD. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT LESS THAN 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) UNK ¿ PLATES THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242573 ↗
• MalfunctionJul 19, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021, DUE TO A BROKEN SCREW. AS IT WAS DIFFICULT TO REMOVE THE FRAGMENT, THE SURGEON LEFT IT IN THE PATIENT¿S BODY. BONE FUSION HAD BEEN OBTAINED. PROCEDURE WAS COMPLETED WITHOUT DELAY. THIS REPORT IS FOR A 5.5 TITANIUM (TI) CORTICAL FIX 7X40MM SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12192870 ↗
• InjuryApr 9, 2018Break; Break

  ON (B)(6) 2014, THE SPINAL SURGERY WAS PERFORMED. THE FIXED ARE WAS L5-S. ON (B)(6) 2018, THE REOPERATION WAS PERFORMED. DURING THE PRE-OPERATIVE MEETING, THE SURGEON PLANNED THAT THE S1 IMPLANTS WOULD BE REPLACED WITH L4-5 VERSE IMPLANTS AFTER THE S1 IMPLANTS WOULD BE REMOVED. WHEN THE SURGEON CHECKED THE X-RAY IMAGES DURING THE PRE-OPERATIVE MEETING, NO BROKEN IMPLANTS WERE FOUND, THE OPERATION WAS PERFORMED AFTER THE MEETING ON THE SAME DAY (ON (B)(6) 2018). AS A USUAL PROCEDURE, THE EXPEDIUM L5-S SET SCREWS AND RODS WERE REMOVED. WHEN THE SURGEON THEN TRIED TO REMOVE THE REPORTED CORTICAL SCREWS, IT WAS FOUND THAT THE REPORTED CORTEX SCREWS WERE BROKEN. THE REPORTED CORTICAL SCREWS ON BOTH RIGHT S1 AND LEFT S1 WERE AFFECTED. THE SURGERY WAS COMPLETED WITH A 60-MINUTE-DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. ((B)(4)).

  Patient problems: Injury; Not Applicable

  MAUDE report 7408274 ↗
• InjuryApr 9, 2018Break; Break

  ON (B)(6) 2014, THE SPINAL SURGERY WAS PERFORMED. THE FIXED ARE WAS L5-S. ON (B)(6) 2018, THE REOPERATION WAS PERFORMED. DURING THE PRE-OPERATIVE MEETING, THE SURGEON PLANNED THAT THE S1 IMPLANTS WOULD BE REPLACED WITH L4-5 VERSE IMPLANTS AFTER THE S1 IMPLANTS WOULD BE REMOVED. WHEN THE SURGEON CHECKED THE X-RAY IMAGES DURING THE PRE-OPERATIVE MEETING, NO BROKEN IMPLANTS WERE FOUND, THE OPERATION WAS PERFORMED AFTER THE MEETING ON THE SAME DAY (ON (B)(6) 2018). AS AN USUAL PROCEDURE, THE EXPEDIUM L5-S SET SCREWS AND RODS WERE REMOVED. WHEN THE SURGEON THEN TRIED TO REMOVE THE REPORTED CORTICAL SCREWS, IT WAS FOUND THAT THE REPORTED CORTEX SCREWS WERE BROKEN. THE REPORTED CORTICAL SCREWS ON BOTH RIGHT S1 AND LEFT S1 WERE AFFECTED. THE SURGERY WAS COMPLETED WITH A 60-MINUTE-DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. (THIS (B)(4) IS RELATED TO (B)(4).

  Patient problems: Injury; Not Applicable

  MAUDE report 7408163 ↗