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EXPEDIUM VERSE 199721000Recalls & reported problems

Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5 · Class 2 · Implant

Quick summary

This Expedium Verse correction key is a tool used with the Expedium Verse spine system to tighten rods and screws during spinal surgery. Its 387 reports include 151 injuries and no deaths, and mostly describe parts bending, breaking or slipping during tightening. Some reports describe infections and paralysis in patients. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
387
Deaths reported
0
Injuries reported
151
Recalls naming it
0

Summary

The FDA's MAUDE database contains 387 adverse event reports that list this exact device (DI 10705034466132), received between Aug 25, 2017 and Jun 9, 2026 — classified as 151 injuries, 236 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (133 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 51 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 5 reportsMar 2025: 0 reportsApr 2025: 5 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 3 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 2 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202651
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Twisted/Bent133
  • Adverse Event Without Identified Device or Use Problem106
  • Break47
  • Device-Device Incompatibility43
  • Material Deformation20
  • Material Split, Cut or Torn17
  • Loose or Intermittent Connection13
  • Material Integrity Problem9

Patient problems

  • No Clinical Signs, Symptoms or Conditions156
  • Unspecified Infection73
  • No Consequences Or Impact To Patient69
  • No Code Available28
  • Neurological Deficit/Dysfunction19
  • Paralysis19
  • Unspecified Nervous System Problem19
  • Injury16

Recent adverse event reports

The 25 most recent of 387 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 9, 2026Mechanical Problem; Material Twisted/Bent

    IT WAS REPORTED WHEN ATTEMPTING TO FINAL TIGHTEN THE INNER ROD SET SCREW DURING SEGMENTAL DENOTATION MANEUVERS DURING A SCOLIOSIS REPAIR SURGERY ON (B)(6) 2026, THE DRIVER SKIPPED OUT, STRIPPED THE SET SCREW AND DID NOT TORQUE PROPERLY DESPITE THE INNER SET SCREW BEING TIGHTENED ALL THE WAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25448188 ↗
  • MalfunctionJun 9, 2026Mechanical Problem; Material Twisted/Bent

    IT WAS REPORTED THAT VERSE CORRECTION KEY AND UNK - SCREWDRIVERS: EXPEDIUM VERSE WERE INVOLVED IN A REPORTED EVENT DURING A SPINAL PROCEDURE. THE EVENT OCCURRED WHEN, DURING FINAL TIGHTENING OF THE INNER ROD SET SCREW WITH THE EXPEDIUM VERSE SET, THE DRIVER FREQUENTLY SKIPPED OUT OR APPEARED TO STRIP THE INNER SET SCREW, FAILING TO CLICK OR TORQUE OUT PROPERLY DESPITE BEING FULLY TIGHTENED. THIS ISSUE WAS NOTED DURING SEGMENTAL DENOTATION MANEUVERS IN A SCOLIOSIS REPAIR SURGERY AND HAS REPORTEDLY BEEN EXPERIENCED IN OTHER ACCOUNTS. THE EVENT RESULTED IN A SURGICAL DELAY OF APPROXIMATELY 10 MINUTES. THE SET SCREWS WERE RE-SET TO ENSURE NO CROSS THREADING AND PROPER POLY HEAD LOCK ENGAGEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, NO FRAGMENTS WERE GENERATED, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THERE WERE NO REPORTED CONSEQUENCES OR IMPACT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25448027 ↗
  • MalfunctionNov 21, 2025Break; Break

    IT WAS REPORTED THE VERSES CORRECTION KEYS AND A SCREW BROKE DURING FINAL TIGHTENING. THE PROCEDURE WAS COMPLETED WITH NO DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23619051 ↗
  • MalfunctionNov 21, 2025Break; Break

    IT WAS REPORTED THE VERSES CORRECTION KEYS AND A SCREW BROKE DURING FINAL TIGHTENING. THE PROCEDURE WAS COMPLETED WITH NO DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23619037 ↗
  • MalfunctionNov 21, 2025Break; Break

    IT WAS REPORTED THE VERSES CORRECTION KEYS AND A SCREW BROKE DURING FINAL TIGHTENING. THE PROCEDURE WAS COMPLETED WITH NO DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23619021 ↗
  • MalfunctionApr 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY TIGHTENING THE EXPEDIUM VERSE CORRECTION KEY DURING THE SPINE PROCEDURE. WHEN THE SURGEON TRIED TO TIGHTEN IT, THE INSTRUMENT SLIPPED, MAKING IT IMPOSSIBLE TO TIGHTEN THE CORRECTION KEY. HOWEVER, WHEN THE CORRECTION KEY WAS REPLACED WITH A NEW ONE, THE SURGEON HAD NO ISSUES AND WAS ABLE TO TIGHTEN IT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

    Patient problems: Insufficient Information

    MAUDE report 21936076 ↗
  • MalfunctionApr 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY TIGHTENING THE EXPEDIUM VERSE CORRECTION KEY DURING THE SPINE PROCEDURE. WHEN THE SURGEON TRIED TO TIGHTEN IT, THE INSTRUMENT SLIPPED, MAKING IT IMPOSSIBLE TO TIGHTEN THE CORRECTION KEY. HOWEVER, WHEN THE CORRECTION KEY WAS REPLACED WITH A NEW ONE, THE SURGEON HAD NO ISSUES AND WAS ABLE TO TIGHTEN IT SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WERE NO COMPLICATIONS OR ADVERSE EFFECT.

    Patient problems: Insufficient Information

    MAUDE report 21762898 ↗
  • MalfunctionApr 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY TIGHTENING THE EXPEDIUM VERSE CORRECTION KEY DURING THE SPINE PROCEDURE. WHEN THE SURGEON TRIED TO TIGHTEN IT, THE INSTRUMENT SLIPPED, MAKING IT IMPOSSIBLE TO TIGHTEN THE CORRECTION KEY. HOWEVER, WHEN THE CORRECTION KEY WAS REPLACED WITH A NEW ONE, THE SURGEON HAD NO ISSUES AND WAS ABLE TO TIGHTEN IT SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WERE NO COMPLICATIONS OR ADVERSE EFFECT.

    Patient problems: Insufficient Information

    MAUDE report 21762893 ↗
  • MalfunctionApr 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY TIGHTENING THE EXPEDIUM VERSE CORRECTION KEY DURING THE SPINE PROCEDURE. WHEN THE SURGEON TRIED TO TIGHTEN IT, THE INSTRUMENT SLIPPED, MAKING IT IMPOSSIBLE TO TIGHTEN THE CORRECTION KEY. HOWEVER, WHEN THE CORRECTION KEY WAS REPLACED WITH A NEW ONE, THE SURGEON HAD NO ISSUES AND WAS ABLE TO TIGHTEN IT SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WERE NO COMPLICATIONS OR ADVERSE EFFECT.

    Patient problems: Insufficient Information

    MAUDE report 21762892 ↗
  • MalfunctionApr 3, 2025Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY TIGHTENING THE EXPEDIUM VERSE CORRECTION KEY DURING THE SPINE PROCEDURE. WHEN THE SURGEON TRIED TO TIGHTEN IT, THE INSTRUMENT SLIPPED, MAKING IT IMPOSSIBLE TO TIGHTEN THE CORRECTION KEY. HOWEVER, WHEN THE CORRECTION KEY WAS REPLACED WITH A NEW ONE, THE SURGEON HAD NO ISSUES AND WAS ABLE TO TIGHTEN IT SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WERE NO COMPLICATIONS OR ADVERSE EFFECT.

    Patient problems: Insufficient Information

    MAUDE report 21762891 ↗
  • MalfunctionFeb 25, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE, THERE WERE PROBLEMS FOR THE LOCKING SCREWS WORKING BECAUSE THEY DID NOT BLOCK THE BAR AFTER PERFORMING THE CORRECTION REQUIRED BY THE SPECIALIST. THIS CAUSED THE DAMAGED LOCKING SCREWS AND THE TRANSPEDICULAR SCREWS WITH DAMAGED THREADS TO BE REPLACED. THREE (3) 5.5 EXP VERSE SCREW 6.0 X 55 AND ONE (1) 5.5 EXP VERSE SCREW 6.0 X 40 SCREWS WERE DAMAGED DUE TO CLOSING SCREWS IN BAD SHAPE. SIX (6) VERSE CORRECTION KEYS DIDN'T BLOCK THE BAR AND IN THE END THE SCREW WERE DAMAGED AND TWO (2) 5.5 EXP VERSE UNITIZED SET SCREWS WERE ALREADY DAMAGED AND AS THEY WERE BEING TIGHTENED, THE THREADS OF THE SCREWS BECAME FURTHER DAMAGED. THIS AFFECTED THE SURGICAL TIME, EXTENDING THE TIME BY APPROXIMATELY ONE (1) HOUR. THE ISSUE ALSO AFFECTED THE PATIENT BECAUSE MORE ANESTHESIA TIME WAS REQUIRED. THIS COMPLAINT IS RELATED TO (B)(4) WHICH REPORTS ADDITIONAL IMPACTED DEVICES.

    Patient problems: Insufficient Information

    MAUDE report 21461243 ↗
  • MalfunctionFeb 25, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE, THERE WERE PROBLEMS FOR THE LOCKING SCREWS WORKING BECAUSE THEY DID NOT BLOCK THE BAR AFTER PERFORMING THE CORRECTION REQUIRED BY THE SPECIALIST. THIS CAUSED THE DAMAGED LOCKING SCREWS AND THE TRANSPEDICULAR SCREWS WITH DAMAGED THREADS TO BE REPLACED. THREE (3) 5.5 EXP VERSE SCREW 6.0 X 55 AND ONE (1) 5.5 EXP VERSE SCREW 6.0 X 40 SCREWS WERE DAMAGED DUE TO CLOSING SCREWS IN BAD SHAPE. SIX (6) VERSE CORRECTION KEYS DIDN'T BLOCK THE BAR AND IN THE END THE SCREW WERE DAMAGED AND TWO (2) 5.5 EXP VERSE UNITIZED SET SCREWS WERE ALREADY DAMAGED AND AS THEY WERE BEING TIGHTENED, THE THREADS OF THE SCREWS BECAME FURTHER DAMAGED. THIS AFFECTED THE SURGICAL TIME, EXTENDING THE TIME BY APPROXIMATELY ONE (1) HOUR. THE ISSUE ALSO AFFECTED THE PATIENT BECAUSE MORE ANESTHESIA TIME WAS REQUIRED. THIS COMPLAINT IS RELATED TO (B)(4) WHICH REPORTS ADDITIONAL IMPACTED DEVICES.

    Patient problems: Insufficient Information

    MAUDE report 21461168 ↗
  • MalfunctionFeb 25, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE, THERE WERE PROBLEMS FOR THE LOCKING SCREWS WORKING BECAUSE THEY DID NOT BLOCK THE BAR AFTER PERFORMING THE CORRECTION REQUIRED BY THE SPECIALIST. THIS CAUSED THE DAMAGED LOCKING SCREWS AND THE TRANSPEDICULAR SCREWS WITH DAMAGED THREADS TO BE REPLACED. THREE (3) 5.5 EXP VERSE SCREW 6.0 X 55 AND ONE (1) 5.5 EXP VERSE SCREW 6.0 X 40 SCREWS WERE DAMAGED DUE TO CLOSING SCREWS IN BAD SHAPE. SIX (6) VERSE CORRECTION KEYS DIDN'T BLOCK THE BAR AND IN THE END THE SCREW WERE DAMAGED AND TWO (2) 5.5 EXP VERSE UNITIZED SET SCREWS WERE ALREADY DAMAGED AND AS THEY WERE BEING TIGHTENED, THE THREADS OF THE SCREWS BECAME FURTHER DAMAGED. THIS AFFECTED THE SURGICAL TIME, EXTENDING THE TIME BY APPROXIMATELY ONE (1) HOUR. THE ISSUE ALSO AFFECTED THE PATIENT BECAUSE MORE ANESTHESIA TIME WAS REQUIRED. THIS COMPLAINT IS RELATED TO (B)(4) WHICH REPORTS ADDITIONAL IMPACTED DEVICES.

    Patient problems: Insufficient Information

    MAUDE report 21461114 ↗
  • MalfunctionFeb 25, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON AUGUST 29, 2024, DURING THE PROCEDURE, THERE WERE PROBLEMS FOR THE LOCKING SCREWS WORKING BECAUSE THEY DID NOT BLOCK THE BAR AFTER PERFORMING THE CORRECTION REQUIRED BY THE SPECIALIST. THIS CAUSED THE DAMAGED LOCKING SCREWS AND THE TRANSPEDICULAR SCREWS WITH DAMAGED THREADS TO BE REPLACED. THREE (3) 5.5 EXP VERSE SCREW 6.0 X 55 AND ONE (1) 5.5 EXP VERSE SCREW 6.0 X 40 SCREWS WERE DAMAGED DUE TO CLOSING SCREWS IN BAD SHAPE. SIX (6) VERSE CORRECTION KEYS DIDN'T BLOCK THE BAR AND IN THE END THE SCREW WERE DAMAGED AND TWO (2) 5.5 EXP VERSE UNITIZED SET SCREWS WERE ALREADY DAMAGED AND AS THEY WERE BEING TIGHTENED, THE THREADS OF THE SCREWS BECAME FURTHER DAMAGED. THIS AFFECTED THE SURGICAL TIME, EXTENDING THE TIME BY APPROXIMATELY ONE (1) HOUR. THE ISSUE ALSO AFFECTED THE PATIENT BECAUSE MORE ANESTHESIA TIME WAS REQUIRED. THIS COMPLAINT IS RELATED TO (B)(4) WHICH REPORTS ADDITIONAL IMPACTED DEVICES.

    Patient problems: Insufficient Information

    MAUDE report 21461028 ↗
  • MalfunctionFeb 25, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON (B)(6)2024, DURING THE PROCEDURE, THERE WERE PROBLEMS FOR THE LOCKING SCREWS WORKING BECAUSE THEY DID NOT BLOCK THE BAR AFTER PERFORMING THE CORRECTION REQUIRED BY THE SPECIALIST. THIS CAUSED THE DAMAGED LOCKING SCREWS AND THE TRANSPEDICULAR SCREWS WITH DAMAGED THREADS TO BE REPLACED. THREE (3) 5.5 EXP VERSE SCREW 6.0 X 55 AND ONE (1) 5.5 EXP VERSE SCREW 6.0 X 40 SCREWS WERE DAMAGED DUE TO CLOSING SCREWS IN BAD SHAPE. SIX (6) VERSE CORRECTION KEYS DIDN'T BLOCK THE BAR AND IN THE END THE SCREW WERE DAMAGED AND TWO (2) 5.5 EXP VERSE UNITIZED SET SCREWS WERE ALREADY DAMAGED AND AS THEY WERE BEING TIGHTENED, THE THREADS OF THE SCREWS BECAME FURTHER DAMAGED. THIS AFFECTED THE SURGICAL TIME, EXTENDING THE TIME BY APPROXIMATELY ONE (1) HOUR. THE ISSUE ALSO AFFECTED THE PATIENT BECAUSE MORE ANESTHESIA TIME WAS REQUIRED. THIS COMPLAINT IS RELATED TO (B)(4) WHICH REPORTS ADDITIONAL IMPACTED DEVICES.

    Patient problems: Insufficient Information

    MAUDE report 21460774 ↗
  • MalfunctionJan 23, 2025Break; Entrapment of Device; Material Twisted/Bent; Break; Entrapment of Device; Material Twisted/Bent

    A SCOLIOSIS CORRECTION WAS DONE WITH THE EXPEDIUM VERSE SYSTEM. ONE OF THE CAPS WAS STRIPPED AND WHEN REMOVING IT, THE HEAD OF THE SCREW WAS DAMAGED, WHERE METALS SHAVINGS CAME OFF. UNFORTUNATELY THE SURGEON HAD TO LEAVE THE SCREW IN AS IT WAS CEMENTED WITH CONFIDENCE CEMENT. IT APPEARS THAT THE CAP WAS CROSS-THREADED AND SEEMED TO HAVE DAMAGED THE HEAD OF THE SCREW. CONSEQUENTLY, THE SURGEON WAS NOT ABLE TO PERFORM FINAL TIGHTENING ON THE UNITIZED SET SCREW. PROCEDURE COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT LISTED AS STABLE.

    Patient problems: Foreign Body In Patient

    MAUDE report 21220642 ↗
  • MalfunctionSep 19, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE IN 2024, THE SET SCREWS STRIPPED ON FINAL TIGHTENING. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE SET SCREWS WERE DISCARDED AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20256105 ↗
  • MalfunctionSep 19, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE IN 2024, THE SET SCREWS STRIPPED ON FINAL TIGHTENING. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE SET SCREWS WERE DISCARDED AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20256101 ↗
  • MalfunctionSep 19, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE IN 2024, THE SET SCREWS STRIPPED ON FINAL TIGHTENING. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE SET SCREWS WERE DISCARDED AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20256086 ↗
  • MalfunctionSep 19, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE IN 2024, THE SET SCREWS STRIPPED ON FINAL TIGHTENING. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE SET SCREWS WERE DISCARDED AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20256083 ↗
  • MalfunctionSep 19, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE IN 2024, THE SET SCREWS STRIPPED ON FINAL TIGHTENING. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE SET SCREWS WERE DISCARDED AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20256080 ↗
  • MalfunctionSep 19, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE IN 2024, THE SET SCREWS STRIPPED ON FINAL TIGHTENING. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE SET SCREWS WERE DISCARDED AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20256069 ↗
  • MalfunctionSep 19, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE IN 2024, THE SET SCREWS STRIPPED ON FINAL TIGHTENING. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE SET SCREWS WERE DISCARDED AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20256066 ↗
  • MalfunctionSep 19, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE IN 2024, THE SET SCREWS STRIPPED ON FINAL TIGHTENING. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE SET SCREWS WERE DISCARDED AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20256062 ↗
  • MalfunctionSep 19, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE IN 2024, THE SET SCREWS STRIPPED ON FINAL TIGHTENING. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE SET SCREWS WERE DISCARDED AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20256057 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.