EXPEDIUM 299704310Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10705034467375), received between Aug 25, 2017 and Jan 13, 2026 — classified as 1 injury, 38 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2025. WHEN USING THE CONSIGNED VERSE, A TAB FROM A PREVIOUS OPERATION WAS FOUND INSIDE THE TAB BREAKER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053169 ↗
• MalfunctionJun 28, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024, THE TAB BREAKER BROKE INTRAOPERATIVE. THIS BREAKAGE LEAD TO A RETAINED FOREIGN BODY. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE EXPEDIUM TAB BREAKER, BODY THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19638803 ↗
• MalfunctionJun 14, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE TAB BREAKER WAS DAMAGED. THE TAB BREAKER END WAS STUCK IN THE BODY. THERE WAS NO PATIENT IMPACT OR DELAY IN SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM TAB BREAKER, BODY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19539047 ↗
• MalfunctionApr 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON MARCH 20, 2024, PREOPERATIVELY, IT WAS DISCOVERED THAT IT WAS NOT POSSIBLE TO PUSH THE CLEARING BOSS INTO DISTAL END OF THE TAB BREAKER. THE INSTRUMENT IS NEW AND HAS NEVER BEEN USED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) EXPEDIUM TAB BREAKER, BODY THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046879 ↗
• MalfunctionMar 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS FURTHER REPORTED THAT THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 18939642 ↗
• MalfunctionMar 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THEY HAD AN ORTHOKIT BOOKING REF1010040401, USING EXPEDIUM VERSE. WHILST DOING THE FINAL STEP OF REMOVING THE TABS, A TAB BECAME LODGED, STUCK IN THE TAB BREAKER, MEANING IT COULD NO LONGER BE USED. AN ALTERNATIVE TOOL WAS USED TO REMOVE THE TABS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) EXPEDIUM TAB BREAKER, BODY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923908 ↗
• MalfunctionFeb 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE TAB BREAKER WAS NOT RETAINING THE VERSE TABS AND THEY WERE FALLING BACK INTO THE SURGICAL SITE. THE SURGEON WAS REQUIRED TO MANUALLY EXTRACT THEM. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE LEAF SPRING OF THE EXPEDIUM TAB BREAKER, BODY WAS DEFORMED. THIS REPORT IS FOR AN EXPEDIUM TAB BREAKER, BODY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691159 ↗
• MalfunctionNov 14, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENTS BROKE. THERE WAS NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) EXPEDIUM TAB BREAKER, BODY THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130474 ↗
• MalfunctionAug 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT REPORTED THAT ON (B)(6) 2023, DURING POST-OP SURGERY, A SALES REP HAD AN EVENTFUL SURGERY WITH MULTIPLE INSTRUMENTS FAILING. LUCKILY FOR EVERYONE, THE INSTRUMENTS WERE FOUND TO BE DYSFUNCTIONAL AFTER THEY WERE USED. THERE WAS NO SURGICAL DELAY. ONE PET30101T HAS A PET30102T LOCKED INTO IT AS WELL, WITH POTENTIAL CONTAMINATION INSIDE. THE OTHER PET30101T HAS ROUGH THREADS, NOT ALLOWING THE PET30102T TO BE INSERTED. THE OTHER PET30102 INSTRUMENTS HAVE CROSSED THREADS AND BECOME DETACHED. THERE WERE NO PATIENT CONSEQUENCES.  THIS REPORT IS FOR ONE (1) EXPEDIUM TAB BREAKER, BODY. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651987 ↗
• MalfunctionAug 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE TAB BREAKER END WAS BROKEN AND THE TLIF SLIDER WAS JAMMED ON (B)(6), 2023. THE DAMAGE WAS IDENTIFIED DURING LOAN KIT INSPECTION. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM TAB BREAKER, BODY. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595469 ↗
• MalfunctionMar 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE TAB BREAKER WAS USED ONE AT A TIME AS TABS WERE FALLING OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620794 ↗
• MalfunctionJun 16, 2022Break; Break

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE CURVED BALL TIP FEELER BROKE IN HALF, AND THE CLASP ON THE TAB BREAKER BROKE, CAUSING IT TO LOSE EFFECTIVENESS. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR AN EXPEDIUM TAB BREAKER, BODY. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14713469 ↗
• MalfunctionJun 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE TAB BREAKER WAS NOT ABLE TO BE ATTACHED EASILY OVER THE TAB. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR AN EXPEDIUM TAB BREAKER, BODY. THIS IS REPORT 1 OF 1FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643107 ↗
• MalfunctionMay 21, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED BY THE SALES REP IN CANADA THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BRAINLAB EXPEDIUM STRAIGHT SHARP BONKER WAS BENT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14464732 ↗
• MalfunctionJan 11, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2021, DURING A PROCEDURE THE SURGEON WAS REMOVING A VERSE TAB WITH THE TAB REMOVAL. THE SURGEON WAS HAVING DIFFICULTY REMOVING ONE OF THE TABS AND ACCIDENTLY BENT THE DISTAL END TIP. THE TAB REMOVER COULD NO LONGER REMOVE THE TABS. ANOTHER TAB REMOVER FROM ANOTHER SET WAS USED TO COMPLETE THE CASE. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM TAB BREAKER, BODY. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13227575 ↗
• MalfunctionJul 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THE PATIENT OUTCOME WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12121222 ↗
• MalfunctionJan 15, 2021Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE, THE TAP BREAKER BROKE THE ENGAGEMENT OF THE DISTAL PART WHEN THE DOCTOR WAS BREAKING THE TABS OF THE EXPEDIUM VERSE SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN EXPEDIUM TAB BREAKER, BODY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11179049 ↗
• MalfunctionNov 25, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT FOR A VERTEBRAL FUSION TREATING PELVIC FRACTURE SURGERY. DURING THE SURGERY, WHEN TIGHTENING THE TAB BREAKER DISCOVERED THAT THERE WAS A TAB REMNANT LEFT IN THE TAB BREAKER. NO PRODUCT DEFECT WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY REPORTED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR (1) EXPEDIUM TAB BREAKER, BODY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10899357 ↗
• MalfunctionOct 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SPINAL FUSION PROCEDURE FOR LUMBAR SPINAL CANAL STENOSIS WAS PERFORMED ON (B)(6) 2020. AFTER THE FOURTH TAB WAS REMOVED, IT BECAME STUCK ON THE TIP OF THE TAB BREAKER BODY. THE SURGEON TRIED TO PUSH IN THE TAB WITH THE TAB BREAKER CAP BUT FAILED. THE HAD TO USE ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE TAB BREAKER BODY WAS THEN USED FOR FOUR MORE TAB REMOVALS. THE PROCEDURE WAS COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ) THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM TAB BREAKER, BODY THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10619615 ↗
• MalfunctionOct 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SPINAL FUSION PROCEDURE FOR LUMBAR SPINAL CANAL STENOSIS WAS PERFORMED ON (B)(6) 2020. AFTER THE FOURTH TAB WAS REMOVED, IT BECAME STUCK ON THE TIP OF THE TAB BREAKER BODY. THE SURGEON TRIED TO PUSH IN THE TAB WITH THE TAB BREAKER CAP BUT FAILED. THE HAD TO USE ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE TAB BREAKER BODY WAS THEN USED FOR FOUR MORE TAB REMOVALS. THE PROCEDURE WAS COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM TAB BREAKER, BODY. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10619607 ↗
• MalfunctionAug 11, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, PRIOR TO USE ON A PATIENT, THE VERSE TAB BREAKER HAD NO SPRING CLIP AND FLAP TO RETAIN TABS. THERE WAS NO PATIENT CONSEQUENCE. UPON INVESTIGATION FINDINGS, THIS COMPLAINT BECAME REPORTABLE AS A MALFUNCTION ON (B)(6) 2020. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM TAB BREAKER, BODY. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10391215 ↗
• MalfunctionJul 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON HAD DIFFICULTY REMOVING THE BROKEN OFF LONG-HEADED TUBE FROM THE TIP. IT COULD ONLY BE REMOVED FROM THE TIP BY USING GREAT FORCE. NO SURGICAL DELAY REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ); UNKNOWN SET SCREW (PART# UNKNOWN, LOT# UNKNOWN , QUANTITY UNKNOWN ). THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM TAB BREAKER, BODY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10339128 ↗
• MalfunctionJul 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, WHILE GOING THROUGH INSTRUMENTS IN STERILE PROCESSING, IT WAS IDENTIFIED THAT AN EXPEDIUM VERSE TAB WAS STUCK WITHIN THE TAB BREAKER. A TAB BREAKER END CAP AS INTENDED TO TRY AND DISLODGE THE TAB FROM THE BREAKER BUT WAS UNSUCCESSFUL. THE TAB REMAINS STUCK WITHIN THE BREAKER. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) EXPEDIUM TAB BREAKER, BODY. THIS IS REPORT 01 OF 02 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323396 ↗
• MalfunctionJun 8, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A SURGERY AND DURING THE SURGERY WHEN THE SURGEON WAS SUTURING, THEY SAW SOMETHING GLISTENING IN THE WOUND AND IT TURNED OUT TO BE THE INNER PART OF THE TAB BREAKER. THE PART THAT SITS INSIDE THE NARROW PART THAT IS PASSED OVER THE TAB ON THE SCREW. IT DID NOT EXTEND THE OPERATION TIME AND THE PATIENT WAS NOT INJURED IN ANY WAY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10130100 ↗
• MalfunctionFeb 24, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE TAB BREAKER BROKE DURING AN UNKNOWN SURGERY. THERE WAS NO REPORTED DELAY TO THE SURGERY. A SIMILAR INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM TAB BREAKER, BODY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9744984 ↗