EXPEDIUM 186100001Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705034103846), received between Oct 16, 2017 and Mar 10, 2020 — classified as 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K071495, K111136); they may or may not involve this specific model.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING GROWING ROD LENGTHENING PROCEDURE, AFTER EXPOSURE OF THE ORIGINAL EXISTING HARDWARE, THE SURGEON DETERMINED THAT THE INTERFACE BETWEEN THE WEDDING BAND CONNECTOR AND THE ROD WAS LOOSE. THE SURGEON COULD IMMEDIATELY TELL THAT THE SINGLE INNIE SET SCREW LOCKED INTO THE CONNECTOR ON THE OPEN SIDE OF THE 4.5 / 4.5 CONNECTOR WAS STRIPPED AND CROSS THREADED. HE THEN ATTEMPTED TO IMPLANT A NEW SINGLE INNIE SET SCREW WHICH IMMEDIATELY CROSS THREADED, REMOVED THAT SET SCREW, AND ALSO THE ORIGINAL 4.5 / 4.5 CONNECTOR. THEN USED IN-SITU BENDERS TO ADJUST THE ROD AND IMPLANTED A NEW CONNECTOR AND DETERMINED THAT THE ORIGINAL WAS DAMAGED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY UNKNOWN); EXP 4.5 TI OP/CLSD 4.5X4.5 (PART#: 186172345, LOT#: UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) EXP 4.5 TI SINGLE INNIE. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS COMPLAINT WILL CAPTURE THE INTRA-OP EVENT (ATTEMPTED TO IMPLANT A NEW SINGLE INNIE SET SCREW WHICH IMMED

  Patient problems: No Code Available

  MAUDE report 9812368 ↗
• InjuryMar 10, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING GROWING ROD LENGTHENING PROCEDURE, AFTER EXPOSURE OF THE ORIGINAL EXISTING HARDWARE, THE SURGEON DETERMINED THAT THE INTERFACE BETWEEN THE WEDDING BAND CONNECTOR AND THE ROD WAS LOOSE. THE SURGEON COULD IMMEDIATELY TELL THAT THE SINGLE INNIE SET SCREW LOCKED INTO THE CONNECTOR ON THE OPEN SIDE OF THE 4.5 / 4.5 CONNECTOR WAS STRIPPED AND CROSS THREADED. HE THEN ATTEMPTED TO IMPLANT A NEW SINGLE INNIE SET SCREW WHICH IMMEDIATELY CROSS THREADED, REMOVED THAT SET SCREW, AND ALSO THE ORIGINAL 4.5 / 4.5 CONNECTOR. THEN USED IN-SITU BENDERS TO ADJUST THE ROD AND IMPLANTED A NEW CONNECTOR AND DETERMINED THAT THE ORIGINAL WAS DAMAGED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); EXP 4.5 TI OP/CLSD 4.5X4.5 (PART# 186172345, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) EXP 4.5 TI SINGLE INNIE. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS COMPLAINT WILL CAPTURE THE INTRA-OP EVENT (ATTEMPTED TO IMPLANT A NEW SINGLE INNIE SET SCREW WHICH IMMEDIATE

  Patient problems: No Code Available

  MAUDE report 9812366 ↗
• InjuryAug 27, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING LENGTHENING OF PRIOR GROWING ROD CONSTRUCT, THE ROD WOULD NOT STAY IN THE OPEN SADDLE OF THE CONNECTOR BECAUSE THE SET SCREWS WOULD STRIP OUT AND FAIL. HE FELT THE COBALT CHROME (COCR) ROD NEEDED TO BE CONTOURED SO IT WOULD LAY IN THE CONNECTOR SADDLE WITHOUT RESISTANCE WHEN PLACING A SET SCREW. THERE WAS A 20-30 MINUTES SURGICAL DELAY, PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS PATIENT HARM/CONSEQUENCE. THIS COMPLAINT INVOLVES SIX (6) DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8938282 ↗
• InjuryAug 27, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING LENGTHENING OF PRIOR GROWING ROD CONSTRUCT, THE ROD WOULD NOT STAY IN THE OPEN SADDLE OF THE CONNECTOR BECAUSE THE SET SCREWS WOULD STRIP OUT AND FAIL. HE FELT THE COBALT CHROME (COCR) ROD NEEDED TO BE CONTOURED SO IT WOULD LAY IN THE CONNECTOR SADDLE WITHOUT RESISTANCE WHEN PLACING A SET SCREW. THERE WAS A 20-30 MINUTES SURGICAL DELAY, PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS PATIENT HARM/CONSEQUENCE. THIS COMPLAINT INVOLVES SIX (6) DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8938258 ↗
• InjuryAug 27, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING LENGTHENING OF PRIOR GROWING ROD CONSTRUCT, THE ROD WOULD NOT STAY IN THE OPEN SADDLE OF THE CONNECTOR BECAUSE THE SET SCREWS WOULD STRIP OUT AND FAIL. HE FELT THE COBALT CHROME (COCR) ROD NEEDED TO BE CONTOURED SO IT WOULD LAY IN THE CONNECTOR SADDLE WITHOUT RESISTANCE WHEN PLACING A SET SCREW. THERE WAS A 20-30 MINUTES SURGICAL DELAY, PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS PATIENT HARM/CONSEQUENCE. THIS COMPLAINT INVOLVES SIX (6) DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8938209 ↗
• InjuryAug 12, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING PROXIMAL CONSTRUCT AND DISTAL CONSTRUCT FOR GROWING ROD FINAL FUSION OF T2-L4, WHILE FINAL TIGHTENING, THE UNKNOWN SET SCREW'S THREAD SHEARED OFF. THIS HAPPENED WHILE NOT USING THE ANTI-TORQUE. ONCE THE SURGEON USED THE ANTI-TORQUE THE SET SCREW DID NOT SHEAR OFF. BUT IT HAPPENED THREE TIMES. THE PATIENT WAS EXPOSED TO ADDITIONAL ANESTHESIA FOR TEN (10) MINUTES. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: POLYAXIAL SCREW (PART # 186112425, LOT# UNKNOWN QUANTITY #3). THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8885165 ↗
• InjuryAug 12, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING PROXIMAL CONSTRUCT AND DISTAL CONSTRUCT FOR GROWING ROD FINAL FUSION OF T2-L4, WHILE FINAL TIGHTENING, THE UNKNOWN SET SCREW'S THREAD SHEARED OFF. THIS HAPPENED WHILE NOT USING THE ANTI-TORQUE. ONCE THE SURGEON USED THE ANTI-TORQUE THE SET SCREW DID NOT SHEAR OFF. BUT IT HAPPENED THREE TIMES. THE PATIENT WAS EXPOSED TO ADDITIONAL ANESTHESIA FOR TEN (10) MINUTES. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: POLYAXIAL SCREW (PART # 186112425, LOT# UNKNOWN QUANTITY #3) THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8884919 ↗
• InjuryAug 12, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING PROXIMAL CONSTRUCT AND DISTAL CONSTRUCT FOR GROWING ROD FINAL FUSION OF T2-L4, WHILE FINAL TIGHTENING, THE UNKNOWN SET SCREW'S THREAD SHEARED OFF. THIS HAPPENED WHILE NOT USING THE ANTI-TORQUE. ONCE THE SURGEON USED THE ANTI-TORQUE THE SET SCREW DID NOT SHEAR OFF. BUT IT HAPPENED THREE TIMES. THE PATIENT WAS EXPOSED TO ADDITIONAL ANESTHESIA FOR TEN (10) MINUTES. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: POLYAXIAL SCREW (PART # 186112425, LOT # UNKNOWN, QUANTITY # 3). THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8884845 ↗
• InjuryMay 22, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT 4.5 TITANIUM EXPEDIUM WITH COBALT CHROME RODS WERE USED. WHEN FINAL TIGHTENING 2 OF THE SET SCREWS WITH THE TORQUE LIMITING DRIVER, THE THREADS SHEARED OFF OF THE SET SCREWS AND THEY HAD TO BE REPLACED. THEY WERE ALREADY DOWN INTO THE SCREW HEAD WHEN THE FINAL TORQUE WAS APPLIED. NO ADVERSE CONSEQUENCE TO THE PATIENT OR ADDITIONAL ANESTHESIA NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631727 ↗
• InjuryMay 22, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT 4.5 TITANIUM EXPEDIUM WITH COBALT CHROME RODS WERE USED. WHEN FINAL TIGHTENING 2 OF THE SET SCREWS WITH THE TORQUE LIMITING DRIVER, THE THREADS SHEARED OFF OF THE SET SCREWS AND THEY HAD TO BE REPLACED. THEY WERE ALREADY DOWN INTO THE SCREW HEAD WHEN THE FINAL TORQUE WAS APPLIED. NO ADVERSE CONSEQUENCE TO THE PATIENT OR ADDITIONAL ANESTHESIA NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631691 ↗
• InjuryJan 3, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DR. (B)(6) DID THE PRIMARY FUSION ON OCTOBER 1ST. THIS FUSION INVOLVED EXPEDIUM 4.5 IN COMBINATION WITH THE SPECIAL ACCESS SYSTEM TROLLEY. DR. (B)(6) MENTIONED THAT HE OVERCORRECTED THE SCOLIOSIS AND THERE WAS A PROXIMAL PULLOUT OF THE CONSTRUCT. BASICALLY THE FIRST SET SCREW ON THE LEFT SIDE OF THE CONSTRUCT AT T3 COMPLETELY CAME OFF AND CONSEQUENTLY THE SCREW AT T4 COMPLETELY PULLED OUT OF THE PEDICLE AS THERE WAS TREMENDOUS STRESS ON THAT SCREW. THIS PARTICULAR SCREW WAS REPLACED WITH A NEW 4.35X30MM AND A NEW ROD AND NEW SET SCREW WAS PLACE ON THE FIRST SCREW. THE PATIENT WAS AFFECTED BY THIS REVISION, INFO IS BELOW. NO REPLACEMENT IS NEEDED. I HAVE NOTHING FURTHER TO ADD. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION:THE PATIENT NEEDED REVISION SURGERY IN ORDER TO CORRECT THE POP OFF CAP AND PULLOUT SCREW. ACTION TAKEN FOR PROCEDURE: REVISION SURGERY. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Code Available

  MAUDE report 8212469 ↗
• InjuryNov 28, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PER REPORTER, MR (B)(6) WAS PERFORMING A DISTRACTION OF GROWING ROD PROCEDURE USING THE CONNECTOR, HE NOTICED THAT THE SET SCREW IN THE CONNECTOR WAS NOT FLUSH AND UPON REMOVING THE SET SCREW AND THE CONNECTOR HE NOTICED SOME METALLOSIS IN THE PATIENTS TISSUE. HE REPLACED THE CONNECTOR AND DISTRACTED THE RODS, WITH NO ISSUES.

  Patient problems: Local Reaction

  MAUDE report 8111012 ↗
• InjuryJun 14, 2018Break; Break

  THE 4.5 TI EXPEDIUM SET SCREW STRIPPED POST OP IN PATIENT. A REVISION TOOK PLACE AND BROKEN SET SCREW WAS REMOVED AND REPACKED WIT HA DIFFERENCE CONSTRUCT. ADDITIONAL INFORMATION RECEIVED FROM REP 23MAY2018: SET SCREW LOOSENED POST -OP. IT WAS DISCOVERED BECAUSE PATIENT IS A CHILD WITH GROWING RODS AND THEY DID X-RAY AT A LATER DATE. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7601946 ↗
• MalfunctionNov 8, 2017Torn Material; Torn Material

  THE SURGEON DISTRACTED THE GROWING ROD CONSTRUCT AND DURING FINAL TIGHTENING, THE SINGLE INNIE SETSCREW STRIPPED OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7008963 ↗
• MalfunctionOct 16, 2017Torn Material; Torn Material

  SURGEON HAD INITIALLY TIGHTENED THE SET SCREWS WITH STANDARD SET SCREW DRIVER. WHEN GOING BACK TO FINAL TIGHTEN, THE SET SCREW DID NOT SEEM TO TIGHTEN/SEAT PROPERLY. THE SURGEON THOUGHT THE TORQUE DRIVER SLIPPED, BUT IT APPEARED THAT THE SET SCREW LOOKED BROKEN. AFTER BACKING OUT THE SET SCREW, IT WAS CLEAR THAT THE PART OF THE THREADS HAD BROKEN OFF IN THE PROCESS OF TIGHTENING. THIS OCCURRED ON 2 SET SCREWS IN THE CONSTRUCT DURING FINAL TIGHTENING AND IT IS UNCLEAR WHETHER ANYTHING WAS CROSS-THREADED OR WHAT MAY HAVE BEEN THE PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6952359 ↗
• MalfunctionOct 16, 2017Torn Material; Torn Material

  SURGEON HAD INITIALLY TIGHTENED THE SET SCREWS WITH STANDARD SET SCREW DRIVER. WHEN GOING BACK TO FINAL TIGHTEN, THE SET SCREW DID NOT SEEM TO TIGHTEN/SEAT PROPERLY. THE SURGEON THOUGHT THE TORQUE DRIVER SLIPPED, BUT IT APPEARED THAT THE SET SCREW LOOKED BROKEN. AFTER BACKING OUT THE SET SCREW, IT WAS CLEAR THAT THE PART OF THE THREADS HAD BROKEN OFF IN THE PROCESS OF TIGHTENING. THIS OCCURRED ON 2 SET SCREWS IN THE CONSTRUCT DURING FINAL TIGHTENING AND IT IS UNCLEAR WHETHER ANYTHING WAS CROSS-THREADED OR WHAT MAY HAVE BEEN THE PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6952239 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071495, K111136. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2015 · Apr 21, 2015 · Terminated
  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467