EXPEDIUM 299704315Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034467368), received between Dec 13, 2017 and Jan 13, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 11 most recent of 11 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 24053167 ↗
• 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, CAP THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046884 ↗
• 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, CAP. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130562 ↗
• 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, CAP THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652016 ↗
• 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, CAP. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13227468 ↗
• MalfunctionJul 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR SPINAL FUSION SURGERY. DURING THE SURGERY, DUE TO INFLEXIBLE TAB BREAKERS, THE SURGEON UNABLE TO CONNECT SCREW TAB TO THE TAB BREAKER AND ALSO, UNABLE TO ATTACH THE CAP TO THE TAB BREAKER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) EXPEDIUM TAB BREAKER, CAP. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12121225 ↗
• 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, CAP. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10619620 ↗
• 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, CAP THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10619612 ↗
• 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 3 DEVICES. THIS REPORT IS FOR (1) EXPEDIUM TAB BREAKER, CAP. THIS IS REPORT 02 OF 02 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323397 ↗
• MalfunctionJan 18, 2019Break; Break

  IT WAS REPORTED THAT THE SURGEON FOUND THAT THE TAB BREAKER (P/N: 299704310 ) TIP WAS BROKEN DURING THE SURGERY PREPARATION (BEFORE STERILIZATION) ON (B)(6) 2018. THE BROKEN DEVICE WILL NOT BE USED FOR THE SURGERY. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261783 ↗
• MalfunctionDec 13, 2017Break; Break

  ON (B)(6) 2017, SURGERY USING THE EXPEDIUM VERSE SYSTEM WAS PERFORMED FOR PROXIMAL/DISTAL ADJACENT KYPHOSIS AFTER THE PROCEDURE OF LUMBER BURSTING FRACTURE. THE FIXED AREA WAS T11-S2. DURING THE SURGERY, THE FOLLOWING WERE CONFIRMED BY THE SURGEON REGARDING TAB BREAKER BODY (PART#: 299704310, LOT#: PU118687) AND TAB BREAKER CAP (PART#: 299704315, LOT#: PU115145). THE TAB BREAKER COULD NOT HOLD THE BROKEN TABS ALREADY REMOVED. THE BROKEN TABS WERE FALLING IN THE OPERATIVE FIELD. AT THE TIME OF BREAKING A COUPLE OF TABS, THE TIP OF TAB BREAKER GOT BROKEN AND DROPPED FROM THE BREAKER BODY. THE SURGEON SUCCESSFULLY REMOVED ALL THE TABS BY CONTINUING TO USE THE BROKEN TAB BREAKER. THE SURGERY WAS COMPLETED WITHOUT ANY DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. IN COMPARISON WITH THE PREVIOUS COMPLAINT PER (B)(4), THE TAB BREAKER GOT BROKEN IN EARLIER STAGE OF THE PROCEDURES. WE ARE REQUIRED TO SUBMIT AN INVESTIGATION REPORT BASED ON OUR MANUFACTURING RECORD AND SO ON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7114538 ↗