EXPEDIUM 186172345Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034108964), received between Nov 8, 2017 and Mar 10, 2020 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K073364, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING GROWING ROD LENGTHENING PROCEDURE ON (B)(6) 2020, 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 NOTICED 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. INFECTION WAS PRESENT AT THE TIME OF THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS SURGICAL DELAY OF TEN (10) MINUTES. THIS REPORT CAPTURES THE POST- OP EVENT (LOOSENING OF THE INTERFACE BETWEEN THE WEDDING BAND CONNECTOR AND THE ROD, SINGLE SET INNIE SCREW WAS STRIPPED AND CROSSED THREADED, INFECTION WAS PRESENT) WHILE RELATED COMPLAINT (B)(4) CAPTURES THE INTRA-OP EVENT (ATTEMPTED TO IMPLANT A NEW SINGLE INNIE SET SCREW WHICH IMMEDIATELY CROSS THREADED). THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9812470 ↗
• 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 8938190 ↗
• 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 8938163 ↗
• 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 8938137 ↗
• 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 "METALOSIS" IN THE PATIENT'S TISSUE. HE REPLACED THE CONNECTOR AND DISTRACTED THE RODS, WITH NO ISSUES.

  Patient problems: Local Reaction

  MAUDE report 8110960 ↗
• 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 7008972 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073364, 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